Impact of oseltamivir treatment on the incidence and course of acute otitis media in children with influenza

Abstract

Objective Acute otitis media (AOM) is the most common complication of pediatric influenza, and imposes a substantial health care burden. We examined the influence of oseltamivir treatment on the incidence and course of AOM in children with influenza. Methods In the original study, 695 children 1–12 years who presented within 48 h of the onset of influenza-like symptoms were randomized to oseltamivir (2 mg/kg) or placebo given twice daily for 5 days. AOM was assessed at enrollment and days 3, 6 (±1), 10 (±2) and 28 (±7). AOM was clinically diagnosed by the participating primary care provider, supported by tympanometry when possible. We performed a retrospective analysis of those participants with laboratory-confirmed influenza (LCI). Assessments included the incidence and clinical course of new AOM cases. Results In all, 452 children had LCI; 217 received oseltamivir and 235 placebo. AOM was diagnosed on or after study day 3 at a significantly lower frequency in the oseltamivir versus placebo group (12.4% versus 21.7%; relative risk [RR]: 0.57 [95% CI: 0.37, 0.88], respectively). Treatment effects were greatest for children 1–2 years (RR = 0.42 [95% CI: 0.20, 0.89]) and 3–5 years (RR = 0.45 [95% CI: 0.19, 1.04]), in whom the incidence of AOM was highest. Conclusions Oseltamivir treatment significantly reduces the emergence of new AOM infections in children with LCI; effects are most pronounced in those <5 years. Clinical trial number: WV15758.