High-dose versus standard-dose amoxicillin for acute otitis media.

Background: Emergence of drug-resistant bacteria has led to a recommendation to use high-dose (HD) amoxicillin (80-90 mg/kg/d) rather than standard-dose (SD) amoxicillin (40-45 mg/kg/d) to treat children with acute otitis media (AOM).

Objective: To compare the efficacy and tolerability of HD versus SD amoxicillin among children with AOM who were considered at low risk for infection with antibiotic-resistant bacteria.

Methods: A double-blind, randomized, 3-year clinical trial was conducted using participants who met the following criteria: age >3 mo, weight
Results: The absolute difference in antibiotic failure rate with SD versus HD amoxicillin at the follow-up visit was nonsignificant (95% CI -1.5% to 3.4%; p = 0.78). The mean duration of illness was similar for both doses of amoxicillin (3 +/- 2 d). The number of office visits and telephone calls related to illness and the number of subsequent AOM episodes did not differ between the 2 treatment groups. HD amoxicillin did not result in a greater incidence of adverse effects than SD amoxicillin.

Conclusions: HD amoxicillin had neither benefit nor detriment compared with SD for AOM in children at low risk for infection with antibiotic-resistant bacteria.