Three clinical trials have examined the efficacy and safety of single dose
azithromycin (30 mg/kg) in children with uncomplicated acute
otitis media (AOM). In the first trial, a small pilot study, the clinical and microbiologic efficacy of single dose
azithromycin was comparable with that of 3-day
azithromycin or single dose
ceftriaxone. A second, non-comparative trial confirmed the clinical and microbiologic efficacy of the single dose regimen. The third study, a large double blind, double dummy trial, demonstrated comparable clinical success rates between single dose
azithromycin and 10-day standard
amoxicillin/
clavulanate. The incidence of
drug-related adverse events in patients treated with single dose
azithromycin was low in all three trials and similar to rates that have been reported for other
antimicrobial agents used for the treatment of patients with AOM. In the
amoxicillin/
clavulanate trial, compliance with single dose
azithromycin was significantly better than with the
amoxicillin/
clavulanate regimen (P < 0.001). We conclude that a single dose of
azithromycin (30 mg/kg) is safe and effective for the treatment of uncomplicated AOM in children.