Healthcare-acquired Infections

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

WASHINGTON – Ridinilazole, a novel, highly specific antibiotic, was safe and showed a sustained clinical response in patients with Clostridioides difficile infection (CDI), according to phase 3 trial results presented at an annual scientific meeting on infectious diseases.

According to the Centers for Disease Control and Prevention, CDI is the top cause of antibiotic-associated diarrhea and one of the most common health care–associated infections in the United States. About 200,000 people in the United States are infected with C. difficile every year in the hospital or clinical care setting.

Most infections are currently treated with vancomycin. Although vancomycin has been shown to be more than 80% effective, it has been linked with recurrence rates ranging from 20% to 30% and interferes with the protective role of the gut microbiome against infection. The current study compared ridinilazole with vancomycin.

Results of the global, double-blinded, randomized trial were presented by Pablo C. Okhuysen, MD, professor of infectious disease at the University of Texas MD Anderson Cancer Center, Houston.

Participants with CDI received a 10-day course of ridinilazole 200 mg twice a day plus placebo or vancomycin 125 mg four times a day. The primary endpoint was sustained clinical response, defined as a clinical response with no recurrent CDI through 30 days after the end of treatment. Recurrent CDI was defined as a new episode of diarrhea with confirmed positive free toxin test requiring additional therapy.

Of the 759 patients enrolled, 745 were included in the modified intention-to-treat  population (ridinilazole, n = 370; vancomycin, n = 375). Ridinilazole achieved a numerically higher rate of sustained clinical response than vancomycin (73.0% vs. 70.7%; P = .467), although the difference was not significant. Ridinilazole also resulted in a significant reduction in recurrence rate (8.1% vs. 17.3%; P < .001).

Ridinilazole’s effect was most notable in a subgroup of patients who were not receiving other antibiotics at time of enrollment – about 70% of participants. In that subgroup, the recurrence rate was 6.7% with ridinilazole versus 16.5% with vancomycin (P < .001), Dr. Okhuysen reported.

“That resulted in a relative risk reduction of 60%,” Dr. Okhuysen told this news organization.

Dr. Okhuysen pointed out that there are currently very few treatment options for CDI other than vancomycin.

“We need new agents to treat C. difficile,” he said, “particularly for those at risk of recurrence. In our study, we found that those exposed to vancomycin had very dramatic shifts in their microbiome.”

Vancomycin depletes the gut microbiome, which decreases the conversion of primary acids to secondary bile acids, the researchers noted.

“A dysbiotic microbiome is fertile ground for C. difficile to grow,” Dr. Okhuysen said. Ridinilazole does not disrupt the microbiome, he added.

Ridinilazole was well-tolerated in the study. The proportion of patients with at least one treatment-emergent adverse effect was 36.4% versus 35.5%, respectively, in the ridinilazole and vancomycin groups. And the proportion who stopped treatment because of treatment-related side effects was 0.8% versus 2.9%.

Mary Hayden, MD, pathology director in the division of infectious diseases at Rush University Medical Center, Chicago, who was not involved with the study, said the results are encouraging as “alternative agents or strategies to prevent recurrence are important to reduce CDI morbidity.”

Its double-blind, randomized, multicenter design strengthens the findings, she explained, adding that “the secondary outcomes of higher concentrations of secondary bile acids and microbiota diversity and composition lend biological plausibility.”

Ridinilazole’s narrow spectrum of activity “should result in less disruption of the colonic microbiota, which has theoretical benefit for both reducing CDI recurrence and for reducing risk of acquisition of multidrug-resistant organisms,” Dr. Hayden said.

Dr. Okhuysen shared that the team is in talks with the Food and Drug Administration and is preparing a manuscript for publication.

The study was supported by Summit Pharmaceuticals and funded by the Biomedical and Advanced Research and Development Authority. Dr. Okhuysen has reported receiving research support from and/or consulting for Summit, Merck, Deinove, Melinta, and Ferring Pharmaceuticals. Some of the coauthors have financial relationships with or received research support from Summit. Dr. Hayden has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The number of adults hospitalized with ventilator-associated pneumonia (VAP) in the United States increased by 50% from 2013 to 2019, based on data from the National Inpatient Sample.

Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.

VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.

To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.

Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.

The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.

A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.

The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.

The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.

The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.

The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.

The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.

The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.

The study received no outside funding. The researchers had no financial conflicts to disclose.

The number of adults hospitalized with ventilator-associated pneumonia (VAP) in the United States increased by 50% from 2013 to 2019, based on data from the National Inpatient Sample.

Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.

VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.

To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.

Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.

The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.

A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.

The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.

The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.

The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.

The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.

The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.

The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.

The study received no outside funding. The researchers had no financial conflicts to disclose.

The number of adults hospitalized with ventilator-associated pneumonia (VAP) in the United States increased by 50% from 2013 to 2019, based on data from the National Inpatient Sample.

Health care–associated infections are a significant burden, and “ventilator associated-pneumonia is a contributor to that,” said Namratha S. Meda, MBBS, in a presentation at the annual meeting of the American College of Chest Physicians.

VAP can affect length of stay and other costs, but factors related to VAP hospitalization have not been well studied, said Dr. Meda, of Medstar Health/Georgetown University Hospital, Washington.

To examine trends in hospitalization for VAP, Dr. Meda and colleagues reviewed data from the National Inpatient Sample from January 2013 to December 2019. The study population included adult patients with VAP as a primary or secondary diagnosis based on ICD-9 or ICD-10 codes.

Overall, the trend in hospitalizations showed a consistent increase, said Dr. Meda.

The researchers identified 128,025 adult hospitalizations with VAP during the study period, with an increase from 50 VAP cases per 100,000 hospitalizations in 2013 to 75 cases per 100,000 hospitalizations in 2019.

A total of 42,120 hospitalizations were associated with tracheostomy, ventilator dependence, or both. Hospitalizations in these categories increased by 80% during the study period, from 15 cases per 100,000 hospitalizations in 2013 to 27 cases per 100,000 hospitalizations in 2019.

The median cost for each hospitalization was $83,311, and showed a 2.9% increase from 2013 to 2019. The estimated annual cost of VAP hospitalizations was approximately $2.8 billion in 2019, Dr. Meda emphasized. However, all-cause hospital mortality remained unchanged over the study period, at approximately 20%.

The mean age of the hospitalized VAP patients was 58 years across all VAP-related hospitalizations, and 36.5% were women. More than half (58%) were White, 21% were Black, and 12% were Hispanic.

The researchers noted some sex and racial disparities; the median age was lower for Black and Hispanic patients, compared with White patients, but all-cause mortality was lower. Men had a significantly longer median length of stay, compared with women (21 days vs. 19 days), and higher median costs ($87,981 vs. $74,889) with a P <.001 for both, but the all-cause in-hospital mortality was not significantly different between sexes.

The steady increase in hospitalization for VAP without a significant change in all-cause mortality, might be driven by hospitals with higher levels of tracheostomy and ventilator dependence, but more research is needed, Dr. Meda noted.

The study was limited by the observational design, which allowed the researchers to report an association, but not causality, said Dr. Meda. However, the results reflect the ongoing financial burden of VAP on the health care system, although “it would be interesting to see how the trend might change if we just looked at the clinical definition versus billing data,” she noted.

The study did not include data since the advent of COVID-19, but COVID is likely to drive the trend of increasing VAP hospitalization higher, Dr. Meda added.

The study received no outside funding. The researchers had no financial conflicts to disclose.

Sepsis survivors discharged to post-acute care facilities are at high risk for mortality and hospital readmission, according to Nicholas Colucciello, MD, and few interventions have been shown to reduce these adverse outcomes.

Dr. Colucciello and colleagues compared the effects of a Sepsis Transition And Recovery (STAR) program versus Usual Care (UC) alone on 30-day mortality and hospital readmission among sepsis survivors discharged to post-acute care.

In a study presented at the annual meeting of the American College of Chest Physicians (CHEST), Dr. Colucciello, a primary care physician in Toledo, Ohio, presented data suggesting that the STAR intervention program appears beneficial for patients discharged to post-acute care facilities and may lead to decreased 30-day mortality and readmission rates.
 

Study of IMPACTS

The study was a secondary analysis of patients from the IMPACTS (Improving Morbidity During Post-Acute Care Transitions for Sepsis) randomized clinical trial, focusing only on those patients who were discharged to a post-acute care facility. IMPACTS evaluated the effectiveness of STAR, a post-sepsis transition program using nurse navigators to deliver best-practice post-sepsis care during and after hospitalization, Dr. Colucciello said. The interventions included comorbidity monitoring, medication review, evaluation for new impairments/symptoms, and goals of care assessment.

“Over one-third of sepsis survivors are discharged to post-acute care as they are not stable enough to go home,” said Dr. Colucciello, and among these patients there is a high risk for mortality and hospital readmission.

Dr. Colucciello and his colleagues randomly assigned patients hospitalized with sepsis and deemed high risk for post-discharge readmission or mortality to either STAR or usual care. The primary outcome was a composite of 30-day readmission and mortality, which was assessed from the electronic health record and social security death master file.

Of the 175 (21%) IMPACTS patients discharged to post-acute care facilities, 143 (82%) were sent to skilled nursing facilities, and 12 (7%) were sent to long-term acute care hospitals. The remaining 20 patients (11%) were sent to inpatient rehabilitation. A total of 88 of these patients received the STAR intervention and 87 received usual care.
 

Suggestive results

The study showed that the composite primary endpoint occurred in 26 (30.6%) patients in the usual care group versus 18 (20.7%) patients in the STAR group, for a risk difference of –9.9% (95% CI, –22.9 to 3.1), according to Dr. Colucciello. As individual factors, 30-day all-cause mortality was 8.2% in the UC group, compared with 5.8% in the STAR group, for a risk difference of –2.5% (95% CI, –10.1 to 5.0) and the 30-day all-cause readmission was 27.1% in the UC group, compared with 17.2% in the STAR program, for a risk difference of –9.8% (95% CI, –22.2 to 2.5). On average, patients receiving UC experienced 26.5 hospital-free days, compared with 27.4 hospital-free days in the STAR group, he added.

The biggest limitation of the study was the fact that it was underpowered to detect statistically significant differences, despite the suggestive results, said Dr. Colucciello. However, he added: “This secondary analysis of the IMPACTS randomized trial found that the STAR intervention may decrease 30-day mortality and readmission rates among sepsis patients discharged to a post-acute care facility,” he concluded.

Dr. Colucciello and colleagues report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Sepsis survivors discharged to post-acute care facilities are at high risk for mortality and hospital readmission, according to Nicholas Colucciello, MD, and few interventions have been shown to reduce these adverse outcomes.

Dr. Colucciello and colleagues compared the effects of a Sepsis Transition And Recovery (STAR) program versus Usual Care (UC) alone on 30-day mortality and hospital readmission among sepsis survivors discharged to post-acute care.

In a study presented at the annual meeting of the American College of Chest Physicians (CHEST), Dr. Colucciello, a primary care physician in Toledo, Ohio, presented data suggesting that the STAR intervention program appears beneficial for patients discharged to post-acute care facilities and may lead to decreased 30-day mortality and readmission rates.
 

Study of IMPACTS

The study was a secondary analysis of patients from the IMPACTS (Improving Morbidity During Post-Acute Care Transitions for Sepsis) randomized clinical trial, focusing only on those patients who were discharged to a post-acute care facility. IMPACTS evaluated the effectiveness of STAR, a post-sepsis transition program using nurse navigators to deliver best-practice post-sepsis care during and after hospitalization, Dr. Colucciello said. The interventions included comorbidity monitoring, medication review, evaluation for new impairments/symptoms, and goals of care assessment.

“Over one-third of sepsis survivors are discharged to post-acute care as they are not stable enough to go home,” said Dr. Colucciello, and among these patients there is a high risk for mortality and hospital readmission.

Dr. Colucciello and his colleagues randomly assigned patients hospitalized with sepsis and deemed high risk for post-discharge readmission or mortality to either STAR or usual care. The primary outcome was a composite of 30-day readmission and mortality, which was assessed from the electronic health record and social security death master file.

Of the 175 (21%) IMPACTS patients discharged to post-acute care facilities, 143 (82%) were sent to skilled nursing facilities, and 12 (7%) were sent to long-term acute care hospitals. The remaining 20 patients (11%) were sent to inpatient rehabilitation. A total of 88 of these patients received the STAR intervention and 87 received usual care.
 

Suggestive results

The study showed that the composite primary endpoint occurred in 26 (30.6%) patients in the usual care group versus 18 (20.7%) patients in the STAR group, for a risk difference of –9.9% (95% CI, –22.9 to 3.1), according to Dr. Colucciello. As individual factors, 30-day all-cause mortality was 8.2% in the UC group, compared with 5.8% in the STAR group, for a risk difference of –2.5% (95% CI, –10.1 to 5.0) and the 30-day all-cause readmission was 27.1% in the UC group, compared with 17.2% in the STAR program, for a risk difference of –9.8% (95% CI, –22.2 to 2.5). On average, patients receiving UC experienced 26.5 hospital-free days, compared with 27.4 hospital-free days in the STAR group, he added.

The biggest limitation of the study was the fact that it was underpowered to detect statistically significant differences, despite the suggestive results, said Dr. Colucciello. However, he added: “This secondary analysis of the IMPACTS randomized trial found that the STAR intervention may decrease 30-day mortality and readmission rates among sepsis patients discharged to a post-acute care facility,” he concluded.

Dr. Colucciello and colleagues report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Sepsis survivors discharged to post-acute care facilities are at high risk for mortality and hospital readmission, according to Nicholas Colucciello, MD, and few interventions have been shown to reduce these adverse outcomes.

Dr. Colucciello and colleagues compared the effects of a Sepsis Transition And Recovery (STAR) program versus Usual Care (UC) alone on 30-day mortality and hospital readmission among sepsis survivors discharged to post-acute care.

In a study presented at the annual meeting of the American College of Chest Physicians (CHEST), Dr. Colucciello, a primary care physician in Toledo, Ohio, presented data suggesting that the STAR intervention program appears beneficial for patients discharged to post-acute care facilities and may lead to decreased 30-day mortality and readmission rates.
 

Study of IMPACTS

The study was a secondary analysis of patients from the IMPACTS (Improving Morbidity During Post-Acute Care Transitions for Sepsis) randomized clinical trial, focusing only on those patients who were discharged to a post-acute care facility. IMPACTS evaluated the effectiveness of STAR, a post-sepsis transition program using nurse navigators to deliver best-practice post-sepsis care during and after hospitalization, Dr. Colucciello said. The interventions included comorbidity monitoring, medication review, evaluation for new impairments/symptoms, and goals of care assessment.

“Over one-third of sepsis survivors are discharged to post-acute care as they are not stable enough to go home,” said Dr. Colucciello, and among these patients there is a high risk for mortality and hospital readmission.

Dr. Colucciello and his colleagues randomly assigned patients hospitalized with sepsis and deemed high risk for post-discharge readmission or mortality to either STAR or usual care. The primary outcome was a composite of 30-day readmission and mortality, which was assessed from the electronic health record and social security death master file.

Of the 175 (21%) IMPACTS patients discharged to post-acute care facilities, 143 (82%) were sent to skilled nursing facilities, and 12 (7%) were sent to long-term acute care hospitals. The remaining 20 patients (11%) were sent to inpatient rehabilitation. A total of 88 of these patients received the STAR intervention and 87 received usual care.
 

Suggestive results

The study showed that the composite primary endpoint occurred in 26 (30.6%) patients in the usual care group versus 18 (20.7%) patients in the STAR group, for a risk difference of –9.9% (95% CI, –22.9 to 3.1), according to Dr. Colucciello. As individual factors, 30-day all-cause mortality was 8.2% in the UC group, compared with 5.8% in the STAR group, for a risk difference of –2.5% (95% CI, –10.1 to 5.0) and the 30-day all-cause readmission was 27.1% in the UC group, compared with 17.2% in the STAR program, for a risk difference of –9.8% (95% CI, –22.2 to 2.5). On average, patients receiving UC experienced 26.5 hospital-free days, compared with 27.4 hospital-free days in the STAR group, he added.

The biggest limitation of the study was the fact that it was underpowered to detect statistically significant differences, despite the suggestive results, said Dr. Colucciello. However, he added: “This secondary analysis of the IMPACTS randomized trial found that the STAR intervention may decrease 30-day mortality and readmission rates among sepsis patients discharged to a post-acute care facility,” he concluded.

Dr. Colucciello and colleagues report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.

“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.

The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.

In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.

To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.

The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).

A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).

Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.

“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.

The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that “the ESM trigger is not improving the time to ordering of antibiotics for septic patients, and we question the utility of this tool in its current state,” he said.

“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”

The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.

“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.

The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.

In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.

To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.

The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).

A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).

Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.

“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.

The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that “the ESM trigger is not improving the time to ordering of antibiotics for septic patients, and we question the utility of this tool in its current state,” he said.

“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”

The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Use of a sepsis predictor made little difference in time to antibiotic administration for septic patients in the emergency department, based on data from more than 200 patients.

“One of the big problems with sepsis is the lack of current tools for early and accurate diagnoses,” said Daniel Burgin, MD, an internal medicine resident at Louisiana State University, Baton Rouge, in a presentation at the annual meeting of the American College of Chest Physicians.

The EPIC Sepsis Model (ESM) was designed to help facilitate earlier detection of sepsis and speed time to the start of antibiotics, but its effectiveness has not been well studied, Dr. Burgin said.

In Dr. Burgin’s facility, the ESM is mainly driven by systemic inflammatory response syndrome (SIRS) and blood pressure and is calculated every 15 minutes; the system triggers a best-practice advisory if needed, with an alert that sepsis may be suspected.

To assess the impact of ESM on time to antibiotics, Dr. Burgin and colleagues reviewed data from 226 adult patients who presented to a single emergency department between February 2019 and June 2019. All patients presented with at least two criteria for SIRS. An ESM threshold of 6 was designed to trigger a set of orders to guide providers on a treatment plan that included antibiotics.

The researchers compared times to the ordering and the administration of antibiotics for patients with ESM scores of 6 or higher vs. less than 6 within 6 hours of triage in the ED. A total of 109 patients (48.2%) received antibiotics in the ED. Of these, 71 (74.5%) had ESM less than 6 and 38 (40.6%) had ESM of 6 or higher. The times from triage to antibiotics ordered and administered was significantly less in patients with ESM of 6 or higher (90.5 minutes vs. 131.5 minutes; 136 minutes vs. 186 minutes, respectively; P = .011 for both).

A total of 188 patients were evaluated for infection, and 86 met Sepsis-2 criteria based on physician chart review. These patients were significantly more likely than those not meeting the Sepsis-2 criteria to receive antibiotics in the ED (76.7% vs. 22.8%; P <.001).

Another 21 patients met criteria for Sepsis-3 based on a physician panel. Although all 21 received antibiotics, 5 did not receive them within 6 hours of triage in the ED, Dr. Burgin said. The median times to ordering and administration of antibiotics for Sepsis-3 patients with an ESM of 6 or higher were –5 and 38.5 (interquartile range), respectively.

“We hope that the ESM would prompt providers to start the order [for antibiotics],” Dr. Burgin said in his presentation. However, the researchers found no consistent patterns, and in many cases the ESM alerts occurred after the orders had been initiated, he noted.

The study findings were limited by the use of data from a single center; the implementation of the EPIC tool is hospital specific, said Dr. Burgin. However, the results suggest that “the ESM trigger is not improving the time to ordering of antibiotics for septic patients, and we question the utility of this tool in its current state,” he said.

“While this research proved useful in assessing the impact of ESM on time to antibiotics, more research is needed to understand how to operationalize predictive analytics,” Dr. Burgin said of the study findings. “The goal is to find the balance between early identification of sepsis and timely antimicrobial therapy and the potential harm of overalerting treatment teams.”

The study was supported in part by Cytovale, a sepsis diagnostics company. Several coauthors disclosed financial relationships with Cytovale. Dr. Burgin reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Four years ago, when Dr. Karen Giuliano went to a Boston hospital for hip replacement surgery, she was given a pale-pink bucket of toiletries issued to patients in many hospitals. Inside were tissues, bar soap, deodorant, toothpaste, and, without a doubt, the worst toothbrush she’d ever seen.

“I couldn’t believe it. I got a toothbrush with no bristles,” she said. “It must have not gone through the bristle machine. It was just a stick.”

To most patients, a useless hospital toothbrush would be a mild inconvenience. But to Dr. Giuliano, a nursing professor at the University of Massachusetts, Amherst, it was a reminder of a pervasive “blind spot” in U.S. hospitals: the stunning consequences of unbrushed teeth.

Hospital patients not getting their teeth brushed, or not brushing their teeth themselves, is believed to be a leading cause of hundreds of thousands of cases of pneumonia a year in patients who have not been put on a ventilator. Pneumonia is among the most common infections that occur in health care facilities, and a majority of cases are nonventilator hospital-acquired pneumonia, or NVHAP, which kills up to 30% of those infected, Dr. Giuliano and other experts said.

But unlike many infections that strike within hospitals, the federal government doesn’t require hospitals to report cases of NVHAP. As a result, few hospitals understand the origin of the illness, track its occurrence, or actively work to prevent it, the experts said.

Many cases of NVHAP could be avoided if hospital staffers more dutifully brushed the teeth of bedridden patients, according to a growing body of peer-reviewed research papers. Instead, many hospitals often skip teeth brushing to prioritize other tasks and provide only cheap, ineffective toothbrushes, often unaware of the consequences, said Dr. Dian Baker, a Sacramento (Calif.) State nursing professor who has spent more than a decade studying NVHAP.

“I’ll tell you that today the vast majority of the tens of thousands of nurses in hospitals have no idea that pneumonia comes from germs in the mouth,” Dr. Baker said.

Pneumonia occurs when germs trigger an infection in the lungs. Although NVHAP accounts for most of the cases that occur in hospitals, it historically has not received the same attention as pneumonia tied to ventilators, which is easier to identify and study because it occurs among a narrow subset of patients.

NVHAP, a risk for virtually all hospital patients, is often caused by bacteria from the mouth that gathers in the scummy biofilm on unbrushed teeth and is aspirated into the lungs. Patients face a higher risk if they lie flat or remain immobile for long periods, so NVHAP can also be prevented by elevating their heads and getting them out of bed more often.

According to the National Organization for NV-HAP Prevention, which was founded in 2020, this pneumonia infects about 1 in every 100 hospital patients and kills 15%-30% of them. For those who survive, the illness often extends their hospital stay by up to 15 days and makes it much more likely they will be readmitted within a month or transferred to an intensive care unit.

John McCleary, 83, of Millinocket, Maine, contracted a likely case of NVHAP in 2008 after he fractured his ankle in a fall and spent 12 days in rehabilitation at a hospital, said his daughter, Kathy Day, a retired nurse and advocate with the Patient Safety Action Network.

Mr. McCleary recovered from the fracture but not from pneumonia. Two days after he returned home, the infection in his lungs caused him to be rushed back to the hospital, where he went into sepsis and spent weeks in treatment before moving to an isolation unit in a nursing home.

He died weeks later, emaciated, largely deaf, unable to eat, and often “too weak to get water through a straw,” his daughter said. After contracting pneumonia, he never walked again.

“It was an astounding assault on his body, from him being here visiting me the week before his fall, to his death just a few months later,” Ms. Day said. “And the whole thing was avoidable.”

While experts describe NVHAP as a largely ignored threat, that appears to be changing.

Last year, a group of researchers – including Dr. Giuliano and Dr. Baker, plus officials from the Centers for Disease Control and Prevention, the Veterans Health Administration, and the Joint Commission – published a “call-to-action” research paper hoping to launch “a national health care conversation about NVHAP prevention.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Four years ago, when Dr. Karen Giuliano went to a Boston hospital for hip replacement surgery, she was given a pale-pink bucket of toiletries issued to patients in many hospitals. Inside were tissues, bar soap, deodorant, toothpaste, and, without a doubt, the worst toothbrush she’d ever seen.

“I couldn’t believe it. I got a toothbrush with no bristles,” she said. “It must have not gone through the bristle machine. It was just a stick.”

To most patients, a useless hospital toothbrush would be a mild inconvenience. But to Dr. Giuliano, a nursing professor at the University of Massachusetts, Amherst, it was a reminder of a pervasive “blind spot” in U.S. hospitals: the stunning consequences of unbrushed teeth.

Hospital patients not getting their teeth brushed, or not brushing their teeth themselves, is believed to be a leading cause of hundreds of thousands of cases of pneumonia a year in patients who have not been put on a ventilator. Pneumonia is among the most common infections that occur in health care facilities, and a majority of cases are nonventilator hospital-acquired pneumonia, or NVHAP, which kills up to 30% of those infected, Dr. Giuliano and other experts said.

But unlike many infections that strike within hospitals, the federal government doesn’t require hospitals to report cases of NVHAP. As a result, few hospitals understand the origin of the illness, track its occurrence, or actively work to prevent it, the experts said.

Many cases of NVHAP could be avoided if hospital staffers more dutifully brushed the teeth of bedridden patients, according to a growing body of peer-reviewed research papers. Instead, many hospitals often skip teeth brushing to prioritize other tasks and provide only cheap, ineffective toothbrushes, often unaware of the consequences, said Dr. Dian Baker, a Sacramento (Calif.) State nursing professor who has spent more than a decade studying NVHAP.

“I’ll tell you that today the vast majority of the tens of thousands of nurses in hospitals have no idea that pneumonia comes from germs in the mouth,” Dr. Baker said.

Pneumonia occurs when germs trigger an infection in the lungs. Although NVHAP accounts for most of the cases that occur in hospitals, it historically has not received the same attention as pneumonia tied to ventilators, which is easier to identify and study because it occurs among a narrow subset of patients.

NVHAP, a risk for virtually all hospital patients, is often caused by bacteria from the mouth that gathers in the scummy biofilm on unbrushed teeth and is aspirated into the lungs. Patients face a higher risk if they lie flat or remain immobile for long periods, so NVHAP can also be prevented by elevating their heads and getting them out of bed more often.

According to the National Organization for NV-HAP Prevention, which was founded in 2020, this pneumonia infects about 1 in every 100 hospital patients and kills 15%-30% of them. For those who survive, the illness often extends their hospital stay by up to 15 days and makes it much more likely they will be readmitted within a month or transferred to an intensive care unit.

John McCleary, 83, of Millinocket, Maine, contracted a likely case of NVHAP in 2008 after he fractured his ankle in a fall and spent 12 days in rehabilitation at a hospital, said his daughter, Kathy Day, a retired nurse and advocate with the Patient Safety Action Network.

Mr. McCleary recovered from the fracture but not from pneumonia. Two days after he returned home, the infection in his lungs caused him to be rushed back to the hospital, where he went into sepsis and spent weeks in treatment before moving to an isolation unit in a nursing home.

He died weeks later, emaciated, largely deaf, unable to eat, and often “too weak to get water through a straw,” his daughter said. After contracting pneumonia, he never walked again.

“It was an astounding assault on his body, from him being here visiting me the week before his fall, to his death just a few months later,” Ms. Day said. “And the whole thing was avoidable.”

While experts describe NVHAP as a largely ignored threat, that appears to be changing.

Last year, a group of researchers – including Dr. Giuliano and Dr. Baker, plus officials from the Centers for Disease Control and Prevention, the Veterans Health Administration, and the Joint Commission – published a “call-to-action” research paper hoping to launch “a national health care conversation about NVHAP prevention.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Four years ago, when Dr. Karen Giuliano went to a Boston hospital for hip replacement surgery, she was given a pale-pink bucket of toiletries issued to patients in many hospitals. Inside were tissues, bar soap, deodorant, toothpaste, and, without a doubt, the worst toothbrush she’d ever seen.

“I couldn’t believe it. I got a toothbrush with no bristles,” she said. “It must have not gone through the bristle machine. It was just a stick.”

To most patients, a useless hospital toothbrush would be a mild inconvenience. But to Dr. Giuliano, a nursing professor at the University of Massachusetts, Amherst, it was a reminder of a pervasive “blind spot” in U.S. hospitals: the stunning consequences of unbrushed teeth.

Hospital patients not getting their teeth brushed, or not brushing their teeth themselves, is believed to be a leading cause of hundreds of thousands of cases of pneumonia a year in patients who have not been put on a ventilator. Pneumonia is among the most common infections that occur in health care facilities, and a majority of cases are nonventilator hospital-acquired pneumonia, or NVHAP, which kills up to 30% of those infected, Dr. Giuliano and other experts said.

But unlike many infections that strike within hospitals, the federal government doesn’t require hospitals to report cases of NVHAP. As a result, few hospitals understand the origin of the illness, track its occurrence, or actively work to prevent it, the experts said.

Many cases of NVHAP could be avoided if hospital staffers more dutifully brushed the teeth of bedridden patients, according to a growing body of peer-reviewed research papers. Instead, many hospitals often skip teeth brushing to prioritize other tasks and provide only cheap, ineffective toothbrushes, often unaware of the consequences, said Dr. Dian Baker, a Sacramento (Calif.) State nursing professor who has spent more than a decade studying NVHAP.

“I’ll tell you that today the vast majority of the tens of thousands of nurses in hospitals have no idea that pneumonia comes from germs in the mouth,” Dr. Baker said.

Pneumonia occurs when germs trigger an infection in the lungs. Although NVHAP accounts for most of the cases that occur in hospitals, it historically has not received the same attention as pneumonia tied to ventilators, which is easier to identify and study because it occurs among a narrow subset of patients.

NVHAP, a risk for virtually all hospital patients, is often caused by bacteria from the mouth that gathers in the scummy biofilm on unbrushed teeth and is aspirated into the lungs. Patients face a higher risk if they lie flat or remain immobile for long periods, so NVHAP can also be prevented by elevating their heads and getting them out of bed more often.

According to the National Organization for NV-HAP Prevention, which was founded in 2020, this pneumonia infects about 1 in every 100 hospital patients and kills 15%-30% of them. For those who survive, the illness often extends their hospital stay by up to 15 days and makes it much more likely they will be readmitted within a month or transferred to an intensive care unit.

John McCleary, 83, of Millinocket, Maine, contracted a likely case of NVHAP in 2008 after he fractured his ankle in a fall and spent 12 days in rehabilitation at a hospital, said his daughter, Kathy Day, a retired nurse and advocate with the Patient Safety Action Network.

Mr. McCleary recovered from the fracture but not from pneumonia. Two days after he returned home, the infection in his lungs caused him to be rushed back to the hospital, where he went into sepsis and spent weeks in treatment before moving to an isolation unit in a nursing home.

He died weeks later, emaciated, largely deaf, unable to eat, and often “too weak to get water through a straw,” his daughter said. After contracting pneumonia, he never walked again.

“It was an astounding assault on his body, from him being here visiting me the week before his fall, to his death just a few months later,” Ms. Day said. “And the whole thing was avoidable.”

While experts describe NVHAP as a largely ignored threat, that appears to be changing.

Last year, a group of researchers – including Dr. Giuliano and Dr. Baker, plus officials from the Centers for Disease Control and Prevention, the Veterans Health Administration, and the Joint Commission – published a “call-to-action” research paper hoping to launch “a national health care conversation about NVHAP prevention.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

A team of surgeons successfully transplanted genetically engineered pig hearts into two recently deceased people whose bodies were being maintained on ventilatory support – not in the hope of restoring life, but as a proof-of-concept experiment in xenotransplantation that could eventually help to ease the critical shortage of donor organs.

The surgeries were performed on June 16 and July 6, 2022, using porcine hearts from animals genetically engineered to prevent organ rejection and promote adaptive immunity by human recipients

“From the very beginning our goal was to be able to create a model where we actually mimicked what is now done clinically in human transplantation, without utilizing unapproved devices or techniques or medications,” said Nader Moazami, MD, surgical director of heart transplantation and chief of the division of heart and lung transplantation and mechanical circulatory support at NYU Langone Health, New York.

158969_OR_heart_transplant_web.jpg

Through 72 hours of postoperative monitoring “we evaluated the heart for functionality and the heart function was completely normal with excellent contractility,” he said at a press briefing announcing early results of the experimental program.

He acknowledged that for the first of the two procedures some surgical modification of the pig heart was required, primarily because of size differences between the donor and recipient.

“Nevertheless, we learned a tremendous amount from the first operation, and when that experience was translated into the second operation it even performed better,” he said.

Alex Reyentovich, MD, medical director of heart transplantation and director of the NYU Langone advanced heart failure program noted that “there are 6 million individuals with heart failure in the United States. About 100,000 of those individuals have end-stage heart failure, and we only do about 3,500 heart transplants a year in the United States, so we have a tremendous deficiency in organs, and there are many people dying waiting for a heart.”

Infection protocols

To date there has been only one xenotransplant of a genetically modified pig heart into a living human recipient, David Bennett Sr., age 57. The surgery, performed at the University of Maryland in January 2022, was initially successful, with the patient able to sit up in bed a few days after the procedure, and the heart performing like a “rock star” according to transplant surgeon Bartley Griffith, MD.

However, Mr. Bennett died 2 months after the procedure from compromise of the organ by an as yet undetermined cause, of which one may have been the heart's infection by porcine cytomegalovirus (CMV).

158969_heart_in_liquid_web.jpg

The NYU team, mindful of this potential setback, used more sensitive assays to screen the donor organs for porcine CMV, and implemented protocols to prevent and to monitor for potential zoonotic transmission of porcine endogenous retrovirus.

The procedure used a dedicated operating room and equipment that will not be used for clinical procedures, the team emphasized.

An organ transplant specialist who was not involved in the study commented that there can be unwelcome surprises even with the most rigorous infection prophylaxis protocols.

“I think these are important steps, but they don’t resolve the question of infectious risk. Sometimes viruses or latent infections are only manifested later,” said Jay A. Fishman, MD, associate director of the Massachusetts General Hospital Transplant Center and director of the transplant infectious diseases and compromised host program at the hospital, which is in Boston.

“I think these are important steps, but as you may recall from the Maryland heart transplant experience, when porcine cytomegalovirus was activated, it was a long way into that patient’s course, and so we just don’t know whether something would have been reactivated later,” he said in an interview.

Dr. Fishman noted that experience with xenotransplantation at the University of Maryland and other centers has suggested that immunosuppressive regimens used for human-to-human transplants may not be suited for animal-to-human grafts.

The hearts were taken from pigs genetically modified with knockouts of four porcine genes to prevent rejection – including a gene for a growth hormone that would otherwise cause the heart to continue to expand in the recipient’s chest – and with the addition of six human transgenes encoding for expression of proteins regulating biologic pathways that might be disrupted by incompatibilities across species.

Vietnam veteran

The organ recipients were recently deceased patients who had expressed the clear wish to be organ donors but whose organs were for clinical reasons unsuitable for transplant.

The first recipient was Lawrence Kelly, a Vietnam War veteran and welder who died from heart failure at the age of 72.

“He was an organ donor, and would be so happy to know how much his contribution to this research will help people like him with this heart disease. He was a hero his whole life, and he went out a hero,” said Alice Michael, Mr. Kelly’s partner of 33 years, who also spoke at the briefing.

“It was, I think, one of the most incredible things to see a pig heart pounding away and beating inside the chest of a human being,” said Robert A. Montgomery, MD, DPhil, director of the NYU Transplant Institute, and himself a heart transplant recipient.

Dr. Fishman said he had no relevant conflicts of interest.

This article was updated on 7/12/22 and 7/14/22.

A team of surgeons successfully transplanted genetically engineered pig hearts into two recently deceased people whose bodies were being maintained on ventilatory support – not in the hope of restoring life, but as a proof-of-concept experiment in xenotransplantation that could eventually help to ease the critical shortage of donor organs.

The surgeries were performed on June 16 and July 6, 2022, using porcine hearts from animals genetically engineered to prevent organ rejection and promote adaptive immunity by human recipients

“From the very beginning our goal was to be able to create a model where we actually mimicked what is now done clinically in human transplantation, without utilizing unapproved devices or techniques or medications,” said Nader Moazami, MD, surgical director of heart transplantation and chief of the division of heart and lung transplantation and mechanical circulatory support at NYU Langone Health, New York.

158969_OR_heart_transplant_web.jpg

Through 72 hours of postoperative monitoring “we evaluated the heart for functionality and the heart function was completely normal with excellent contractility,” he said at a press briefing announcing early results of the experimental program.

He acknowledged that for the first of the two procedures some surgical modification of the pig heart was required, primarily because of size differences between the donor and recipient.

“Nevertheless, we learned a tremendous amount from the first operation, and when that experience was translated into the second operation it even performed better,” he said.

Alex Reyentovich, MD, medical director of heart transplantation and director of the NYU Langone advanced heart failure program noted that “there are 6 million individuals with heart failure in the United States. About 100,000 of those individuals have end-stage heart failure, and we only do about 3,500 heart transplants a year in the United States, so we have a tremendous deficiency in organs, and there are many people dying waiting for a heart.”

Infection protocols

To date there has been only one xenotransplant of a genetically modified pig heart into a living human recipient, David Bennett Sr., age 57. The surgery, performed at the University of Maryland in January 2022, was initially successful, with the patient able to sit up in bed a few days after the procedure, and the heart performing like a “rock star” according to transplant surgeon Bartley Griffith, MD.

However, Mr. Bennett died 2 months after the procedure from compromise of the organ by an as yet undetermined cause, of which one may have been the heart's infection by porcine cytomegalovirus (CMV).

158969_heart_in_liquid_web.jpg

The NYU team, mindful of this potential setback, used more sensitive assays to screen the donor organs for porcine CMV, and implemented protocols to prevent and to monitor for potential zoonotic transmission of porcine endogenous retrovirus.

The procedure used a dedicated operating room and equipment that will not be used for clinical procedures, the team emphasized.

An organ transplant specialist who was not involved in the study commented that there can be unwelcome surprises even with the most rigorous infection prophylaxis protocols.

“I think these are important steps, but they don’t resolve the question of infectious risk. Sometimes viruses or latent infections are only manifested later,” said Jay A. Fishman, MD, associate director of the Massachusetts General Hospital Transplant Center and director of the transplant infectious diseases and compromised host program at the hospital, which is in Boston.

“I think these are important steps, but as you may recall from the Maryland heart transplant experience, when porcine cytomegalovirus was activated, it was a long way into that patient’s course, and so we just don’t know whether something would have been reactivated later,” he said in an interview.

Dr. Fishman noted that experience with xenotransplantation at the University of Maryland and other centers has suggested that immunosuppressive regimens used for human-to-human transplants may not be suited for animal-to-human grafts.

The hearts were taken from pigs genetically modified with knockouts of four porcine genes to prevent rejection – including a gene for a growth hormone that would otherwise cause the heart to continue to expand in the recipient’s chest – and with the addition of six human transgenes encoding for expression of proteins regulating biologic pathways that might be disrupted by incompatibilities across species.

Vietnam veteran

The organ recipients were recently deceased patients who had expressed the clear wish to be organ donors but whose organs were for clinical reasons unsuitable for transplant.

The first recipient was Lawrence Kelly, a Vietnam War veteran and welder who died from heart failure at the age of 72.

“He was an organ donor, and would be so happy to know how much his contribution to this research will help people like him with this heart disease. He was a hero his whole life, and he went out a hero,” said Alice Michael, Mr. Kelly’s partner of 33 years, who also spoke at the briefing.

“It was, I think, one of the most incredible things to see a pig heart pounding away and beating inside the chest of a human being,” said Robert A. Montgomery, MD, DPhil, director of the NYU Transplant Institute, and himself a heart transplant recipient.

Dr. Fishman said he had no relevant conflicts of interest.

This article was updated on 7/12/22 and 7/14/22.

A team of surgeons successfully transplanted genetically engineered pig hearts into two recently deceased people whose bodies were being maintained on ventilatory support – not in the hope of restoring life, but as a proof-of-concept experiment in xenotransplantation that could eventually help to ease the critical shortage of donor organs.

The surgeries were performed on June 16 and July 6, 2022, using porcine hearts from animals genetically engineered to prevent organ rejection and promote adaptive immunity by human recipients

“From the very beginning our goal was to be able to create a model where we actually mimicked what is now done clinically in human transplantation, without utilizing unapproved devices or techniques or medications,” said Nader Moazami, MD, surgical director of heart transplantation and chief of the division of heart and lung transplantation and mechanical circulatory support at NYU Langone Health, New York.

158969_OR_heart_transplant_web.jpg

Through 72 hours of postoperative monitoring “we evaluated the heart for functionality and the heart function was completely normal with excellent contractility,” he said at a press briefing announcing early results of the experimental program.

He acknowledged that for the first of the two procedures some surgical modification of the pig heart was required, primarily because of size differences between the donor and recipient.

“Nevertheless, we learned a tremendous amount from the first operation, and when that experience was translated into the second operation it even performed better,” he said.

Alex Reyentovich, MD, medical director of heart transplantation and director of the NYU Langone advanced heart failure program noted that “there are 6 million individuals with heart failure in the United States. About 100,000 of those individuals have end-stage heart failure, and we only do about 3,500 heart transplants a year in the United States, so we have a tremendous deficiency in organs, and there are many people dying waiting for a heart.”

Infection protocols

To date there has been only one xenotransplant of a genetically modified pig heart into a living human recipient, David Bennett Sr., age 57. The surgery, performed at the University of Maryland in January 2022, was initially successful, with the patient able to sit up in bed a few days after the procedure, and the heart performing like a “rock star” according to transplant surgeon Bartley Griffith, MD.

However, Mr. Bennett died 2 months after the procedure from compromise of the organ by an as yet undetermined cause, of which one may have been the heart's infection by porcine cytomegalovirus (CMV).

158969_heart_in_liquid_web.jpg

The NYU team, mindful of this potential setback, used more sensitive assays to screen the donor organs for porcine CMV, and implemented protocols to prevent and to monitor for potential zoonotic transmission of porcine endogenous retrovirus.

The procedure used a dedicated operating room and equipment that will not be used for clinical procedures, the team emphasized.

An organ transplant specialist who was not involved in the study commented that there can be unwelcome surprises even with the most rigorous infection prophylaxis protocols.

“I think these are important steps, but they don’t resolve the question of infectious risk. Sometimes viruses or latent infections are only manifested later,” said Jay A. Fishman, MD, associate director of the Massachusetts General Hospital Transplant Center and director of the transplant infectious diseases and compromised host program at the hospital, which is in Boston.

“I think these are important steps, but as you may recall from the Maryland heart transplant experience, when porcine cytomegalovirus was activated, it was a long way into that patient’s course, and so we just don’t know whether something would have been reactivated later,” he said in an interview.

Dr. Fishman noted that experience with xenotransplantation at the University of Maryland and other centers has suggested that immunosuppressive regimens used for human-to-human transplants may not be suited for animal-to-human grafts.

The hearts were taken from pigs genetically modified with knockouts of four porcine genes to prevent rejection – including a gene for a growth hormone that would otherwise cause the heart to continue to expand in the recipient’s chest – and with the addition of six human transgenes encoding for expression of proteins regulating biologic pathways that might be disrupted by incompatibilities across species.

Vietnam veteran

The organ recipients were recently deceased patients who had expressed the clear wish to be organ donors but whose organs were for clinical reasons unsuitable for transplant.

The first recipient was Lawrence Kelly, a Vietnam War veteran and welder who died from heart failure at the age of 72.

“He was an organ donor, and would be so happy to know how much his contribution to this research will help people like him with this heart disease. He was a hero his whole life, and he went out a hero,” said Alice Michael, Mr. Kelly’s partner of 33 years, who also spoke at the briefing.

“It was, I think, one of the most incredible things to see a pig heart pounding away and beating inside the chest of a human being,” said Robert A. Montgomery, MD, DPhil, director of the NYU Transplant Institute, and himself a heart transplant recipient.

Dr. Fishman said he had no relevant conflicts of interest.

This article was updated on 7/12/22 and 7/14/22.

Teamwork by a wide range of professional staff, coupled with support from leadership, enabled one academic community hospital to cut its rate of hospital-onset Clostridioides difficile infections (HO-CDIs) by almost two-thirds in 1 year and by over three-quarters in 3 years, a study published in the American Journal of Infection Control reports.

C. diff. is a major health threat. According to the U.S. Centers for Disease Control and Prevention, CDIs, mainly linked with hospitals, caused an estimated 223,900 cases in hospitalized patients and 12,800 deaths in the United States in 2017.

“The interventions and outcomes of the project improved patient care by ensuring early testing, diagnosis, treatment if warranted, and proper isolation, which helped reduce C. diff. transmission to staff and other patients,” lead study author Cherith Walter, MSN, RN, a clinical nurse specialist at Emory Saint Joseph’s Hospital, Atlanta, told this news organization. “Had we not worked together as a team, we would not have had the ability to carry out such a robust project,” she added in an email.

Each HO-CDI case costs a health care system an estimated $12,313, and high rates of HO-CDIs incur fines from the Hospital-Acquired Condition Reduction Program of the Centers for Medicare & Medicaid Services (CMS), the authors write.
 

A diverse staff team collaborated

Emory Saint Joseph’s, a 410-bed hospital in Atlanta, had a history of being above the national CMS benchmark for HO-CDIs. To reduce these infections, comply with CMS requirements, and avoid fines, Ms. Walter and colleagues launched a quality improvement project between 2015 and 2020.

With the approval of the chief nursing officer, chief quality officer, and hospital board, researchers mobilized a diverse team of professionals: a clinical nurse specialist, a physician champion, unit nurse champions, a hospital epidemiologist, an infection preventionist, a clinical microbiologist, an antimicrobial stewardship pharmacist, and an environmental services representative.

The team investigated what caused their hospital’s HO-CDIs from 2014 through 2016 and developed appropriate, evidence-based infection prevention interventions. The integrated approach involved:

• Diagnostic stewardship, including a diarrhea decision-tree algorithm that enabled nurses to order tests of any loose or unformed stool for C. diff. during the first 3 days of admission.
• Enhanced environmental cleaning, which involved switching from sporicidal disinfectant only in isolation rooms to using a more effective Environmental Protection Agency–approved sporicidal disinfectant containing hydrogen peroxide and peracetic acid in all patient rooms for daily cleaning and after discharge. Every day, high-touch surfaces in C. diff. isolation rooms were cleaned and shared equipment was disinfected with bleach wipes. After patient discharge, staff cleaned mattresses on all sides, wiped walls with disinfectant, and used ultraviolet light.
• Antimicrobial stewardship. Formulary fluoroquinolones were removed as standalone orders and made available only through order sets with built-in clinical decision support.
• Education of staff on best practices, through emails, flyers, meetings, and training sessions. Two nurses needed to approve the appropriateness of testing specific specimens for CDI. All HO-CDIs were reviewed and findings presented at CDI team meetings.
• Accountability. Staff on the team and units received emailed notices about compliance issues and held meetings to discuss how to improve compliance.

After 1 year, HO-CDI incidence dropped 63% from baseline, from above 12 cases per 10,000 patient-days to 4.72 per 10,000 patient-days. And after 3 years, infections dropped 77% to 2.80 per 10,000 patient-days.

The hospital’s HO-CDI standardized infection ratio – the total number of infections divided by the National Healthcare Safety Network’s risk-adjusted predicted number of infections – dropped below the national benchmark, from 1.11 in 2015 to 0.43 in 2020.

The hospital also increased testing of appropriate patients for CDI within the first 3 days of admission, from 54% in 2014 to 81% in late 2019.

“By testing patients within 3 days of admission, we discovered that many had acquired C. diff. before admission,” Ms. Walter said. “I don’t think we realized how prevalent C. diff. was in the community.”

Benjamin D. Galvan, MLS(ASCP), CIC, an infection preventionist at Tampa General Hospital and a member of the Association for Professionals in Infection Control and Epidemiology, welcomed the study’s results.  

“Effective collaboration within the health care setting is a highly effective way to implement and sustain evidence-based practices related to infection reduction. When buy-in is obtained from the top, and pertinent stakeholders are engaged for their expertise, we can see sustainable change and improved patient outcomes,” Mr. Galvan, who was not involved in the study, said in an email.

“The researchers did a fantastic job,” he added. “I am grateful to see this important work addressed in the literature, as it will only improve buy-in for improvement efforts aimed at reducing infections moving forward across the health care continuum.”

Douglas S. Paauw, MD, a professor of medicine and chair for patient-centered clinical education at the University of Washington School of Medicine, Seattle, said that the team’s most important interventions were changing the environmental cleaning protocol and using agents that kill C. diff. spores.

“We know that as many as 10%-20% of hospitalized patients carry C. diff. Cleaning only the rooms where you know you have C. diff. (isolation rooms) will miss most of it,” said Dr. Paauw, who was also not involved in the study. “Cleaning every room with cleaners that actually work is very important but costs money.”
 

Handwashing with soap and water works, alcohol hand gels do not

“We know that handwashing with soap and water is the most important way to prevent hospital C. diff. transmission,” Dr. Paauw noted. “Handwashing protocols implemented prior to the study were probably a big part of the team’s success.”

Handwashing with soap and water works but alcohol hand gels do not, he cautioned.

“C. diff. rates in hospitals went up years ago when we started putting alcohol gels outside patients’ rooms,” Dr. Paauw explained. “Now, instead of washing their hands, staff quickly pump gel before they see patients. Applying gel is easy, but gel does not eliminate C. diff. spores. Handwashing is such a simple way to fix the C. diff. problem, but doctors don’t take the time.”

“We need to take the C. diff. problem seriously. We have enough information, and we know the right things to do. We need to wash our hands. We need to clean the rooms. We need to stop cutting corners if we want to give good care,” he said.

The authors plan to conduct further related research.

The study was not funded. All study authors, as well as Mr. Galvan and Dr. Paauw, have reported no relevant financial interests.

A version of this article first appeared on Medscape.com.

Teamwork by a wide range of professional staff, coupled with support from leadership, enabled one academic community hospital to cut its rate of hospital-onset Clostridioides difficile infections (HO-CDIs) by almost two-thirds in 1 year and by over three-quarters in 3 years, a study published in the American Journal of Infection Control reports.

C. diff. is a major health threat. According to the U.S. Centers for Disease Control and Prevention, CDIs, mainly linked with hospitals, caused an estimated 223,900 cases in hospitalized patients and 12,800 deaths in the United States in 2017.

“The interventions and outcomes of the project improved patient care by ensuring early testing, diagnosis, treatment if warranted, and proper isolation, which helped reduce C. diff. transmission to staff and other patients,” lead study author Cherith Walter, MSN, RN, a clinical nurse specialist at Emory Saint Joseph’s Hospital, Atlanta, told this news organization. “Had we not worked together as a team, we would not have had the ability to carry out such a robust project,” she added in an email.

Each HO-CDI case costs a health care system an estimated $12,313, and high rates of HO-CDIs incur fines from the Hospital-Acquired Condition Reduction Program of the Centers for Medicare & Medicaid Services (CMS), the authors write.
 

A diverse staff team collaborated

Emory Saint Joseph’s, a 410-bed hospital in Atlanta, had a history of being above the national CMS benchmark for HO-CDIs. To reduce these infections, comply with CMS requirements, and avoid fines, Ms. Walter and colleagues launched a quality improvement project between 2015 and 2020.

With the approval of the chief nursing officer, chief quality officer, and hospital board, researchers mobilized a diverse team of professionals: a clinical nurse specialist, a physician champion, unit nurse champions, a hospital epidemiologist, an infection preventionist, a clinical microbiologist, an antimicrobial stewardship pharmacist, and an environmental services representative.

The team investigated what caused their hospital’s HO-CDIs from 2014 through 2016 and developed appropriate, evidence-based infection prevention interventions. The integrated approach involved:

• Diagnostic stewardship, including a diarrhea decision-tree algorithm that enabled nurses to order tests of any loose or unformed stool for C. diff. during the first 3 days of admission.
• Enhanced environmental cleaning, which involved switching from sporicidal disinfectant only in isolation rooms to using a more effective Environmental Protection Agency–approved sporicidal disinfectant containing hydrogen peroxide and peracetic acid in all patient rooms for daily cleaning and after discharge. Every day, high-touch surfaces in C. diff. isolation rooms were cleaned and shared equipment was disinfected with bleach wipes. After patient discharge, staff cleaned mattresses on all sides, wiped walls with disinfectant, and used ultraviolet light.
• Antimicrobial stewardship. Formulary fluoroquinolones were removed as standalone orders and made available only through order sets with built-in clinical decision support.
• Education of staff on best practices, through emails, flyers, meetings, and training sessions. Two nurses needed to approve the appropriateness of testing specific specimens for CDI. All HO-CDIs were reviewed and findings presented at CDI team meetings.
• Accountability. Staff on the team and units received emailed notices about compliance issues and held meetings to discuss how to improve compliance.

After 1 year, HO-CDI incidence dropped 63% from baseline, from above 12 cases per 10,000 patient-days to 4.72 per 10,000 patient-days. And after 3 years, infections dropped 77% to 2.80 per 10,000 patient-days.

The hospital’s HO-CDI standardized infection ratio – the total number of infections divided by the National Healthcare Safety Network’s risk-adjusted predicted number of infections – dropped below the national benchmark, from 1.11 in 2015 to 0.43 in 2020.

The hospital also increased testing of appropriate patients for CDI within the first 3 days of admission, from 54% in 2014 to 81% in late 2019.

“By testing patients within 3 days of admission, we discovered that many had acquired C. diff. before admission,” Ms. Walter said. “I don’t think we realized how prevalent C. diff. was in the community.”

Benjamin D. Galvan, MLS(ASCP), CIC, an infection preventionist at Tampa General Hospital and a member of the Association for Professionals in Infection Control and Epidemiology, welcomed the study’s results.  

“Effective collaboration within the health care setting is a highly effective way to implement and sustain evidence-based practices related to infection reduction. When buy-in is obtained from the top, and pertinent stakeholders are engaged for their expertise, we can see sustainable change and improved patient outcomes,” Mr. Galvan, who was not involved in the study, said in an email.

“The researchers did a fantastic job,” he added. “I am grateful to see this important work addressed in the literature, as it will only improve buy-in for improvement efforts aimed at reducing infections moving forward across the health care continuum.”

Douglas S. Paauw, MD, a professor of medicine and chair for patient-centered clinical education at the University of Washington School of Medicine, Seattle, said that the team’s most important interventions were changing the environmental cleaning protocol and using agents that kill C. diff. spores.

“We know that as many as 10%-20% of hospitalized patients carry C. diff. Cleaning only the rooms where you know you have C. diff. (isolation rooms) will miss most of it,” said Dr. Paauw, who was also not involved in the study. “Cleaning every room with cleaners that actually work is very important but costs money.”
 

Handwashing with soap and water works, alcohol hand gels do not

“We know that handwashing with soap and water is the most important way to prevent hospital C. diff. transmission,” Dr. Paauw noted. “Handwashing protocols implemented prior to the study were probably a big part of the team’s success.”

Handwashing with soap and water works but alcohol hand gels do not, he cautioned.

“C. diff. rates in hospitals went up years ago when we started putting alcohol gels outside patients’ rooms,” Dr. Paauw explained. “Now, instead of washing their hands, staff quickly pump gel before they see patients. Applying gel is easy, but gel does not eliminate C. diff. spores. Handwashing is such a simple way to fix the C. diff. problem, but doctors don’t take the time.”

“We need to take the C. diff. problem seriously. We have enough information, and we know the right things to do. We need to wash our hands. We need to clean the rooms. We need to stop cutting corners if we want to give good care,” he said.

The authors plan to conduct further related research.

The study was not funded. All study authors, as well as Mr. Galvan and Dr. Paauw, have reported no relevant financial interests.

A version of this article first appeared on Medscape.com.

Teamwork by a wide range of professional staff, coupled with support from leadership, enabled one academic community hospital to cut its rate of hospital-onset Clostridioides difficile infections (HO-CDIs) by almost two-thirds in 1 year and by over three-quarters in 3 years, a study published in the American Journal of Infection Control reports.

C. diff. is a major health threat. According to the U.S. Centers for Disease Control and Prevention, CDIs, mainly linked with hospitals, caused an estimated 223,900 cases in hospitalized patients and 12,800 deaths in the United States in 2017.

“The interventions and outcomes of the project improved patient care by ensuring early testing, diagnosis, treatment if warranted, and proper isolation, which helped reduce C. diff. transmission to staff and other patients,” lead study author Cherith Walter, MSN, RN, a clinical nurse specialist at Emory Saint Joseph’s Hospital, Atlanta, told this news organization. “Had we not worked together as a team, we would not have had the ability to carry out such a robust project,” she added in an email.

Each HO-CDI case costs a health care system an estimated $12,313, and high rates of HO-CDIs incur fines from the Hospital-Acquired Condition Reduction Program of the Centers for Medicare & Medicaid Services (CMS), the authors write.
 

A diverse staff team collaborated

Emory Saint Joseph’s, a 410-bed hospital in Atlanta, had a history of being above the national CMS benchmark for HO-CDIs. To reduce these infections, comply with CMS requirements, and avoid fines, Ms. Walter and colleagues launched a quality improvement project between 2015 and 2020.

With the approval of the chief nursing officer, chief quality officer, and hospital board, researchers mobilized a diverse team of professionals: a clinical nurse specialist, a physician champion, unit nurse champions, a hospital epidemiologist, an infection preventionist, a clinical microbiologist, an antimicrobial stewardship pharmacist, and an environmental services representative.

The team investigated what caused their hospital’s HO-CDIs from 2014 through 2016 and developed appropriate, evidence-based infection prevention interventions. The integrated approach involved:

• Diagnostic stewardship, including a diarrhea decision-tree algorithm that enabled nurses to order tests of any loose or unformed stool for C. diff. during the first 3 days of admission.
• Enhanced environmental cleaning, which involved switching from sporicidal disinfectant only in isolation rooms to using a more effective Environmental Protection Agency–approved sporicidal disinfectant containing hydrogen peroxide and peracetic acid in all patient rooms for daily cleaning and after discharge. Every day, high-touch surfaces in C. diff. isolation rooms were cleaned and shared equipment was disinfected with bleach wipes. After patient discharge, staff cleaned mattresses on all sides, wiped walls with disinfectant, and used ultraviolet light.
• Antimicrobial stewardship. Formulary fluoroquinolones were removed as standalone orders and made available only through order sets with built-in clinical decision support.
• Education of staff on best practices, through emails, flyers, meetings, and training sessions. Two nurses needed to approve the appropriateness of testing specific specimens for CDI. All HO-CDIs were reviewed and findings presented at CDI team meetings.
• Accountability. Staff on the team and units received emailed notices about compliance issues and held meetings to discuss how to improve compliance.

After 1 year, HO-CDI incidence dropped 63% from baseline, from above 12 cases per 10,000 patient-days to 4.72 per 10,000 patient-days. And after 3 years, infections dropped 77% to 2.80 per 10,000 patient-days.

The hospital’s HO-CDI standardized infection ratio – the total number of infections divided by the National Healthcare Safety Network’s risk-adjusted predicted number of infections – dropped below the national benchmark, from 1.11 in 2015 to 0.43 in 2020.

The hospital also increased testing of appropriate patients for CDI within the first 3 days of admission, from 54% in 2014 to 81% in late 2019.

“By testing patients within 3 days of admission, we discovered that many had acquired C. diff. before admission,” Ms. Walter said. “I don’t think we realized how prevalent C. diff. was in the community.”

Benjamin D. Galvan, MLS(ASCP), CIC, an infection preventionist at Tampa General Hospital and a member of the Association for Professionals in Infection Control and Epidemiology, welcomed the study’s results.  

“Effective collaboration within the health care setting is a highly effective way to implement and sustain evidence-based practices related to infection reduction. When buy-in is obtained from the top, and pertinent stakeholders are engaged for their expertise, we can see sustainable change and improved patient outcomes,” Mr. Galvan, who was not involved in the study, said in an email.

“The researchers did a fantastic job,” he added. “I am grateful to see this important work addressed in the literature, as it will only improve buy-in for improvement efforts aimed at reducing infections moving forward across the health care continuum.”

Douglas S. Paauw, MD, a professor of medicine and chair for patient-centered clinical education at the University of Washington School of Medicine, Seattle, said that the team’s most important interventions were changing the environmental cleaning protocol and using agents that kill C. diff. spores.

“We know that as many as 10%-20% of hospitalized patients carry C. diff. Cleaning only the rooms where you know you have C. diff. (isolation rooms) will miss most of it,” said Dr. Paauw, who was also not involved in the study. “Cleaning every room with cleaners that actually work is very important but costs money.”
 

Handwashing with soap and water works, alcohol hand gels do not

“We know that handwashing with soap and water is the most important way to prevent hospital C. diff. transmission,” Dr. Paauw noted. “Handwashing protocols implemented prior to the study were probably a big part of the team’s success.”

Handwashing with soap and water works but alcohol hand gels do not, he cautioned.

“C. diff. rates in hospitals went up years ago when we started putting alcohol gels outside patients’ rooms,” Dr. Paauw explained. “Now, instead of washing their hands, staff quickly pump gel before they see patients. Applying gel is easy, but gel does not eliminate C. diff. spores. Handwashing is such a simple way to fix the C. diff. problem, but doctors don’t take the time.”

“We need to take the C. diff. problem seriously. We have enough information, and we know the right things to do. We need to wash our hands. We need to clean the rooms. We need to stop cutting corners if we want to give good care,” he said.

The authors plan to conduct further related research.

The study was not funded. All study authors, as well as Mr. Galvan and Dr. Paauw, have reported no relevant financial interests.

A version of this article first appeared on Medscape.com.

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Clostridioides difficile infection is often confirmed through toxin testing, yet toxin tests alone may not be sufficient for diagnosing and guiding treatment decisions for patients with CDI.

“The presence of a toxigenic strain does not always equal disease,” said David Lyerly, PhD, during a session on C. difficile toxin testing at the Peggy Lillis Foundation 2022 National C. diff Advocacy Summit.

Dr. Lyerly, the chief science officer at Techlab, explained that exotoxins A and B are produced by specific strains of C. difficile and are involved in infections, but some patients who test positive for these toxins by polymerase chain reaction or other tests do not have CDI or they are not appropriate candidates for CDI treatment.

Several studies conducted during the past decade, however, support the importance of toxin detection. Some research has suggested that toxin-positive patients tend to have more clinically severe disease than those who test negative, he noted.

Although its use is limited when it is used alone, toxin testing is needed to confirm a CDI diagnosis and to ensure antibiotic stewardship, Dr. Lyerly said.

He suggested that, in addition to toxin testing, there is a need for molecular measures and other improved diagnostics to identify candidates most likely to benefit from CDI treatment.

“Because we generally detect toxin genes instead of toxin proteins, you can identify persons colonized with toxigenic C. difficile who do not actually have CDI,” Kevin W. Garey, PharmD, from the University of Houston, said in an interview.

Dr. Garey added that a person could likewise have low levels of toxins that aren’t detected by toxin tests but could still have CDI.

“Given this, better diagnostics that incorporate active toxin production and your body’s response to those toxins are needed,” he said, especially since C. difficile toxins are responsible for disease sequelae, including gastroenteritis, colonic perforation, sepsis, and death.
 

Toxin testing a ‘controversial area’

“C. difficile toxin testing has been a controversial area for almost a decade or more,” Shruti K. Gohil, MD, from University of California, Irvine, Health Epidemiology and Infection Prevention, said in an interview.

Dr. Gohil noted that toxin testing is a better test for clinical C. difficile colitis but by itself can miss C. difficile. “So, we are in this conundrum nationally,” she said.

“Many facilities will use a double- or triple-test strategy to make sure that you have a true C. difficile case mandating the use of antibiotics,” she explained. “The reason we test specifically with the enzyme immunoassay or toxin test is to know whether or not you have real C. difficile that’s actively producing the toxin for colitis.”

A patient with C. difficile who has been treated and is in recovery may still test positive on a C. difficile toxin test, added Dr. Gohil. “It would be great if we had a test that could really judge an active, clinical C. difficile infection. This [test] would help in identifying the right patients who need treatment and would also be able to tell if a patient has been cleared of C. difficile.”

Dr. Lyerly is an employee of Techlab. Dr. Garey and Dr. Gohil reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Clostridioides difficile infection is often confirmed through toxin testing, yet toxin tests alone may not be sufficient for diagnosing and guiding treatment decisions for patients with CDI.

“The presence of a toxigenic strain does not always equal disease,” said David Lyerly, PhD, during a session on C. difficile toxin testing at the Peggy Lillis Foundation 2022 National C. diff Advocacy Summit.

Dr. Lyerly, the chief science officer at Techlab, explained that exotoxins A and B are produced by specific strains of C. difficile and are involved in infections, but some patients who test positive for these toxins by polymerase chain reaction or other tests do not have CDI or they are not appropriate candidates for CDI treatment.

Several studies conducted during the past decade, however, support the importance of toxin detection. Some research has suggested that toxin-positive patients tend to have more clinically severe disease than those who test negative, he noted.

Although its use is limited when it is used alone, toxin testing is needed to confirm a CDI diagnosis and to ensure antibiotic stewardship, Dr. Lyerly said.

He suggested that, in addition to toxin testing, there is a need for molecular measures and other improved diagnostics to identify candidates most likely to benefit from CDI treatment.

“Because we generally detect toxin genes instead of toxin proteins, you can identify persons colonized with toxigenic C. difficile who do not actually have CDI,” Kevin W. Garey, PharmD, from the University of Houston, said in an interview.

Dr. Garey added that a person could likewise have low levels of toxins that aren’t detected by toxin tests but could still have CDI.

“Given this, better diagnostics that incorporate active toxin production and your body’s response to those toxins are needed,” he said, especially since C. difficile toxins are responsible for disease sequelae, including gastroenteritis, colonic perforation, sepsis, and death.
 

Toxin testing a ‘controversial area’

“C. difficile toxin testing has been a controversial area for almost a decade or more,” Shruti K. Gohil, MD, from University of California, Irvine, Health Epidemiology and Infection Prevention, said in an interview.

Dr. Gohil noted that toxin testing is a better test for clinical C. difficile colitis but by itself can miss C. difficile. “So, we are in this conundrum nationally,” she said.

“Many facilities will use a double- or triple-test strategy to make sure that you have a true C. difficile case mandating the use of antibiotics,” she explained. “The reason we test specifically with the enzyme immunoassay or toxin test is to know whether or not you have real C. difficile that’s actively producing the toxin for colitis.”

A patient with C. difficile who has been treated and is in recovery may still test positive on a C. difficile toxin test, added Dr. Gohil. “It would be great if we had a test that could really judge an active, clinical C. difficile infection. This [test] would help in identifying the right patients who need treatment and would also be able to tell if a patient has been cleared of C. difficile.”

Dr. Lyerly is an employee of Techlab. Dr. Garey and Dr. Gohil reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Clostridioides difficile infection is often confirmed through toxin testing, yet toxin tests alone may not be sufficient for diagnosing and guiding treatment decisions for patients with CDI.

“The presence of a toxigenic strain does not always equal disease,” said David Lyerly, PhD, during a session on C. difficile toxin testing at the Peggy Lillis Foundation 2022 National C. diff Advocacy Summit.

Dr. Lyerly, the chief science officer at Techlab, explained that exotoxins A and B are produced by specific strains of C. difficile and are involved in infections, but some patients who test positive for these toxins by polymerase chain reaction or other tests do not have CDI or they are not appropriate candidates for CDI treatment.

Several studies conducted during the past decade, however, support the importance of toxin detection. Some research has suggested that toxin-positive patients tend to have more clinically severe disease than those who test negative, he noted.

Although its use is limited when it is used alone, toxin testing is needed to confirm a CDI diagnosis and to ensure antibiotic stewardship, Dr. Lyerly said.

He suggested that, in addition to toxin testing, there is a need for molecular measures and other improved diagnostics to identify candidates most likely to benefit from CDI treatment.

“Because we generally detect toxin genes instead of toxin proteins, you can identify persons colonized with toxigenic C. difficile who do not actually have CDI,” Kevin W. Garey, PharmD, from the University of Houston, said in an interview.

Dr. Garey added that a person could likewise have low levels of toxins that aren’t detected by toxin tests but could still have CDI.

“Given this, better diagnostics that incorporate active toxin production and your body’s response to those toxins are needed,” he said, especially since C. difficile toxins are responsible for disease sequelae, including gastroenteritis, colonic perforation, sepsis, and death.
 

Toxin testing a ‘controversial area’

“C. difficile toxin testing has been a controversial area for almost a decade or more,” Shruti K. Gohil, MD, from University of California, Irvine, Health Epidemiology and Infection Prevention, said in an interview.

Dr. Gohil noted that toxin testing is a better test for clinical C. difficile colitis but by itself can miss C. difficile. “So, we are in this conundrum nationally,” she said.

“Many facilities will use a double- or triple-test strategy to make sure that you have a true C. difficile case mandating the use of antibiotics,” she explained. “The reason we test specifically with the enzyme immunoassay or toxin test is to know whether or not you have real C. difficile that’s actively producing the toxin for colitis.”

A patient with C. difficile who has been treated and is in recovery may still test positive on a C. difficile toxin test, added Dr. Gohil. “It would be great if we had a test that could really judge an active, clinical C. difficile infection. This [test] would help in identifying the right patients who need treatment and would also be able to tell if a patient has been cleared of C. difficile.”

Dr. Lyerly is an employee of Techlab. Dr. Garey and Dr. Gohil reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.

Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.

“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.

Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.

They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.

The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.

Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.

Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).

CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.

Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).

Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).

People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.

People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
 

Reactions from four experts

Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”

Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.

David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.

“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.

In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.

“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”

Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.

“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.

Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.

The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.

Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.

“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.

Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.

They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.

The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.

Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.

Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).

CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.

Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).

Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).

People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.

People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
 

Reactions from four experts

Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”

Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.

David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.

“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.

In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.

“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”

Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.

“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.

Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.

The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Hospitalized patients who are asymptomatic Clostridioides difficile carriers may infect people they live with after they return home, a study based on U.S. insurance claim data suggests.

Although C. difficile infection (CDI) is considered to be a common hospital-acquired infection, reports of community-associated CDI in patients who have not been hospitalized are increasing, the authors wrote in Emerging Infectious Diseases.

“Individuals in households where another family member was recently hospitalized but not diagnosed with a CDI appear to be at increased risk for CDI,” said lead author Aaron C. Miller, PhD, a research assistant professor in the department of internal medicine at the University of Iowa, Iowa City. “When individuals are hospitalized, they may become colonized with C. difficile without developing symptoms and subsequently transmit the pathogen to other family members after they return home,” he said by email.

Dr. Miller and colleagues analyzed insurance claims data from 2001 through 2017 using the U.S. Commercial Claims and Medicare Supplemental datasets of IBM MarketScan Research Databases. Over that period, they searched employer-sponsored commercial insurance claims and Medicare supplemental claims of 194,424 enrollees, and they linked claims from multiple family members in the same enrollment plan.

They identified 224,818 CDI cases, and 3,871 of them were considered potential asymptomatic C. difficile transmissions from a recently hospitalized family member.

The researchers gathered monthly C. difficile incidence data from households with a family member who had been hospitalized within the past 60 days and compared them with data from households without a hospitalized family member.

Enrollees exposed to a recently hospitalized family member had a 73% greater incidence of CDI compared with enrollees who were not exposed. The longer the family member’s hospital stay, the greater the risk that someone in the household became infected.

Compared with people whose family members were hospitalized less than 1 day, people whose family members were hospitalized from 1 to 3 days had an incidence rate ratio (IRR) of 1.30 (95% confidence interval [CI], 1.19-1.41), and those whose family members were hospitalized for more than 30 days had an IRR of 2.45 (95% CI, 1.66-3.60).

CDI incidence increased with age. Compared with people 17 years of age or younger, the IRR increased to 9.32 (95% CI, 8.92-9.73) for those over 65.

Females had higher CDI incidence than males (IRR 1.30; 95% CI, 1.28-1.33).

Households with an infant also had higher CDI incidence than those without (IRR 1.5; 95% CI, 1.44-1.58).

People taking antimicrobials had higher CDI IRRs: 2.69 (95% CI, 2.59-2.79) for low-CDI-risk antibiotics and 8.83 (95% CI, 8.63-9.03) for high-CDI-risk antibiotics.

People taking proton-pump inhibitors had an IRR of 2.23 (95% CI, 2.15-2.30).
 

Reactions from four experts

Douglas S. Paauw MD, MACP, professor of medicine and the chair for patient-centered clinical education at the University of Washington, Seattle, was not surprised by the findings. “We have wondered for a while how community-acquired CDI occurs,” he said in an email. “This important study offers a plausible explanation for some cases.”

Dr. Paauw advises doctors to consider CDI in their patients who have been exposed to hospitalized people.

David M. Aronoff, MD, FIDSA, FAAM, professor of medicine and the chair of the department of medicine at Indiana University, Indianapolis, advises providers to educate hospital patients being discharged about how CDI is spread and how they can practice good hand hygiene at home.

“An open question of this strong study is whether we should be testing certain hospital patients for asymptomatic C. difficile carriage before they are discharged,” he added in an email.

In a phone interview, Paul G. Auwaerter, MD, MBA, professor of medicine and clinical director of the division of infectious diseases at Johns Hopkins University, Baltimore, noted that community-acquired CDI is frequent enough that his institution performs routine C. difficile testing on all patients with unexplained severe diarrhea.

“This intriguing study bears additional research and follow-up because clearly these spores are hardy,” he said. “But a key point in this billings- and claims-based study is that no one knows where household members acquired CDI, whether it was actually through household transmission.”

Ramin Asgary, MD, MPH, FASTMH, associate professor of global health in the Milken Institute School of Public Health at George Washington University, Washington, cautioned about “an increasing issue with drug-resistant CDI.

“This important, timely study provides another step in the right direction to better understanding and addressing CDI and other hospital-based infections that have become increasing threats to the safety of our patients, their families, and health care in general,” he said in an email.

Dr. Miller said that the scale and scope of the data are strengths of the study, and he acknowledged that its basis in claims and billing data is a limitation. He and his group plan to explore genetic relationships involved in CDI transmission.

The study was funded by the Centers for Disease Control and Prevention. All authors and independent experts have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.