Single-dose azithromycin for the treatment of children with acute otitis media.

Azithromycin is an azalide with in vitro activity against otitis media pathogens, good middle ear penetration and a prolonged half-life. A total of four clinical trials have evaluated the clinical success rate, safety and compliance of single-dose azithromycin (30 mg/kg) in the treatment of children with otitis media. Among all the patients treated with single-dose azithromycin (30 mg/kg), and presented previously in four published clinical trials, end-of-treatment clinical success was 88% (544 out of 619) and maintained clinical success at the end-of-study was 82% (498 out of 610). Three of the four studies included a mandatory baseline tympanocentesis. The overall end-of-treatment and end-of-study clinical success rates among all culture-positive patients was 84% (222 out of 263) and 80% (210 out of 263), respectively. Per pathogen end-of-treatment clinical success rates observed were 91% (125 out of 137) among patients with Streptococcus pneumoniae, 77% (75 out of 97) among patients with Haemophilus influenzae, 100% (14 out of 14) among patients with Moraxella catarrhalis, 64% (seven out of 11) among patients with baseline Streptococcus pyogenes and 25% (one out of four) among patients with a S. pneumoniae and H. influenzae mixed infection. Clinical success was observed in 90% (106 out of 118) of patients with baseline macrolide-susceptible S. pneumoniae and in 67% (14 out of 21) among patients with baseline macrolide-resistant S. pneumoniae (p = 0.01). Adverse events were uncommon, mostly mild and transitory gastrointestinal complaints, and in the two larger comparative trials, were less frequent than the rates observed with the comparator agents. Compliance was excellent (99-100%). Single-dose azithromycin (30 mg/kg) represents an alternative for the treatment of pediatric patients with uncomplicated acute otitis media, particularly in those geographic regions where high-level S. pneumoniae macrolide resistance is uncommon, and for those patients that require directly observed therapy or when compliance may be a problem.