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

Int J Pediatr Otorhinolaryngol. 2010 Jun;74(6):684-8. doi: 10.1016/j.ijporl.2010.03.024. Epub 2010 Apr 3.


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 48h of the onset of influenza-like symptoms were randomized to oseltamivir (2mg/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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acoustic Impedance Tests
  • Acute Disease
  • Antiviral Agents / therapeutic use*
  • Child
  • Child, Preschool
  • Cost of Illness
  • Female
  • Humans
  • Incidence
  • Infant
  • Influenza, Human / drug therapy*
  • Influenza, Human / epidemiology*
  • Male
  • Oseltamivir / therapeutic use*
  • Otitis Media / diagnosis
  • Otitis Media / epidemiology*


  • Antiviral Agents
  • Oseltamivir