In this double-blind, double-dummy, multinational, clinical trial, children between the ages of 6 and 30 months with uncomplicated AOM were randomized to treatment with single-dose azithromycin or high-dose amoxicillin (90 mg/kg/day, in 2 div doses) for 10 days. The primary outcome measure was clinical efficacy assessed at the end of treatment on the basis of a modified intent-to-treat (MITT) population. Secondary outcomes were analyses of safety and compliance. Three hundred thirteen patients were enrolled, of whom 83% were <2 years old, with 158 patients randomized to receive azithromycin and 154 to receive amoxicillin. Tympanocentesis was performed at baseline, and clinical responses were assessed at days 12–14 (end of therapy) and 25–28 (end of study). A middle-ear pathogen was detected in 212 patients (68%). H. Influenzae was the most common pathogen isolated (96 cases), followed by S. pneumoniae (92), M. catarrhalis (23), and S. pyogenes (23). At the end of therapy, clinical success rates for azithromycin and amoxicillin were comparable for all patients (84% and 84%, respectively) and for children <2 years of age (82% and 82%, respectively). At the end of the study, clinical efficacies among all microbiologic modified intent-to-treat evaluable subjects were comparable for patients treated with azithro(80%) and patients treated with amoxicillin (83%). The rates of adverse events for azithromycin and amoxicillin were 20% and 29%, respectively (p=.064). Diarrhea was more common in the amoxicillin group (17.5%) as compared to the azithromycin group (8.2%) (p=.017). Compliance, defined as completion of >80% of the study medications, was higher in the azithromycin group (100%) then in the amoxicillin group (90%) (p=.001). For practitioners ordering medications, compliance and efficacy are uppermost considerations. Single-dose azithromycin ensured 100% compliance, decreased adverse reactions, and equal efficacy, compared to high-dose amoxicillin in this well designed, randomized, controlled trial. (Jadad Score = 4/5) all patients (84% and 84%, respectively) and for children <2 years of age (82% and 82%, respectively). At the end of the study, clinical efficacies among all microbiologic modified intent-to-treat evaluable subjects were comparable for patients treated with azithromycin (80%) and patients treated with amoxicillin (83%). The rates of adverse events for azithromycin and amoxicillin were 20% and 29%, respectively
(p=.064). Diarrhea was more common in the amoxicillin group (17.5%) as compared to the azithromycin group (8.2%) (p=.017). Compliance, defined as completion of >80% of the study medications, was higher in the azithromycin group (100%) then in the amoxicillin group (90%) (p=.001). For practitioners ordering medications, compliance and efficacy are uppermost considerations. Single-dose azithromycin ensured 100% compliance, decreased adverse reactions, and equal efficacy, compared to high-dose amoxicillin in this well-designed, randomized, controlled trial. (Jadad Score = 4/5)