Treatment of uncomplicated acute otitis media with single-dose azithromycin proved comparable in efficacy to the standard high-dose amoxicillin in an international trial of young children.
Azithromycin treatment for acute otitis media (AOM) also showed fewer adverse events and greater patient compliance in the randomized, double-blind, double-dummy trial, reported Adriano Arguedas, M.D., of the Instituto de Atención Pediátrica, San José, Costa Rica, and colleagues.
In a trial conducted at centers in Chile, Costa Rica, Finland, and the United States, 312 children 6-30 months of age with AOM were divided into two study populations (Pediatr. Infect. Dis. J. 2005;24:153-61).
The 158 patients in the azithromycin group received a single dose of the drug (30 mg/kg) plus 10 days of an amoxicillin placebo at 90 mg/kg per day, in two divided doses. The 154 patients in the amoxicillin group received an azithromycin placebo and 10 days of authentic amoxicillin. Clinical success was reported as cure or improvement at end of therapy and maintenance of cure at end of study. It was not significantly different between the treatments. Rates at end of therapy were 84% for each antibiotic for all patients and 82% for each antibiotic for children 2 years of age or younger. Rates at end of study for all patients were 77% for azithromycin and 78% for amoxicillin and 75% for both antibiotics for children aged 2 years and younger.
The rates of treatment-related adverse events for azithromycin and amoxicillin were 20% and 29%, respectively. Although adverse events rates were not significantly different overall, significant differences were seen in the incidence of diarrhea, which was greater with amoxicillin than with azithromycin (17.5% vs. 8.2%).
Compliance, defined as completion of at least 80% of the prescribed study medication, was significantly greater in the azithromycin group (100% vs. 90%).
The authors concluded single-dose azithromycin was noninferior to standard high-dose amoxicillin. The study was supported by a grant from Pfizer Inc., which makes azithromycin (Zithromax).