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 </=18 kg, diagnosed with AOM, and candidates for treatment with amoxicillin. The primary endpoint was treatment success at a 3- to 4-day follow-up visit based on the clinical decision to continue the prescribed antibiotic therapy for AOM. Other endpoints included duration of illness, number of office visits and telephone calls related to illness, total number of subsequent AOM episodes, and number of adverse effects.
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.