A multicenter, double blind comparison of azithromycin and amoxicillin/clavulanate for the treatment of acute otitis media in children

Objective, To compare the efficacy and safety of azithromycin and amoxicillin/clavulanate in pediatric acute otitis media. Methods, Investigators from 12 US centers recruited 677 children, In a randomized, double blind, double dummy fashion, participants received either azithromycin suspension (n = 341) once daily for 5 days or amoxicillin/clavulanate suspension (n = 336) in three divided doses daily for 10 days. Results, Among evaluable patients satisfactory clinical response rates (cured and improved) measured 11 days after therapy began were 87.5% in the azithromycin group and 87.9% in the amoxicillin/clavulanate group; corresponding rates at 30 days were 73.5% in the azithromycin and 71.2% in the amoxicillin/clavulanate groups. Relapse rates were comparable for the treatment groups, Treatment-related side effects, primarily gastrointestinal, were reported significantly less frequently with azithromycin (8.8%) than with amoxicillin/clavulanate (30.8%) (P < 0.0001), Two (0.6%) azithromycin patients and 12 (3.6%) amoxicillin/clavulanate patients discontinued therapy because of treatment-related side effects (P < 0.006 between groups). Conclusions, In these children with acute otitis media, azithromycin given once daily for 5 days and amoxicillin/clavulanate given three times daily for 10 days had similar efficacy; however, azithromycin was significantly better tolerated.