SAN FRANCISCO — Children with respiratory tract infection and their parents generally preferred treatment with clarithromycin granules sipped through a strawlike device than with conventional clarithromycin suspension syrup, Dr. Dieter Adam reported.
A randomized, open-label study in 263 children aged 2–12 years treated for 7–10 days found no significant difference in efficacy after completion of the therapy, with the bacterial organism eradicated in 93% by either formulation.
In the sipping group, however, 23% had clinical symptoms resolve in 3–5 days compared with 13% in the suspension group, he said in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy.
Parents assessed the sipped formulation as easier to administer and better tasting to the child, compared with the suspension form.
Rates of adherence to therapy were significantly higher with the sipped form than with the suspension in the first 5 days of therapy (92% vs. 38%) and at the end of treatment (94% vs. 86%), said Dr. Adam, a pediatrician at the University of Munich, Germany, and his associates.
The study was funded by Grünenthal GmbH, which markets the Siptechnology formulation in Latin America and some European countries. The company is pursuing U.S. approval, said Dr. Adam, who has no other affiliation with the company.
The Siptechnology consists of a plastic strawlike device loaded with a dose of drug granules with a film coating to mask the taste. The study randomized patients in a 2:1 ratio to the Siptechnology or suspension syrup. Children in the Siptechnology group used the device to sip their preferred soft drink through a liquid-permeable controller on the end of the “straw,” ingesting both the soda and drug granules.
Both regimens delivered 15 mg/kg per day divided into two equal doses. Patients were treated for acute otitis media in 20% of cases, tonsillitis in 25%, pharyngitis in 30%, and acute bronchitis in 42%. (Some children had more than one infection.)
“Normally, clarithromycin has a bitter taste” that may interfere with adherence and might reduce cure rates in the real world compared with the Siptechnology, although efficacy was comparable in this trial setting, Dr. Adam said at the conference, sponsored by the American Society for Microbiology.
Patients or their parents reported the taste was good or very good in 62% of the Siptechnology group compared with 36% of the suspension group. Patients ingested the drug without resistance or resentment in 88% of doses in the Siptechnology group and 67% of doses in the suspension group.