Journal Article

Early Oseltamivir Treatment of Influenza in Children 1–3 Years of Age: A Randomized Controlled Trial

Santtu Heinonen, Heli Silvennoinen, Pasi Lehtinen, Raija Vainionpää, Tero Vahlberg, Thedi Ziegler, Niina Ikonen, Tuomo Puhakka and Terho Heikkinen

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 51, issue 8, pages 887-894
Published in print October 2010 | ISSN: 1058-4838
Published online October 2010 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/656408
Early Oseltamivir Treatment of Influenza in Children 1–3 Years of Age: A Randomized Controlled Trial

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Background. Oseltamivir provides modest clinical benefits to children with influenza when started within 48 hours of symptom onset. The effectiveness of oseltamivir could be substantially greater if the treatment were started earlier during the course of the illness.

Methods. We carried out a randomized, double-blind, placebo-controlled trial of the efficacy of oseltamivir started within 24 hours of symptom onset in children 1–3 years of age with laboratory-confirmed influenza during the seasons of 2007–2008 and 2008–2009. Eligible children received either orally administered oseltamivir suspension or a matching placebo twice daily for 5 days. The children received clinical examinations, and the parents filled out detailed symptom diaries for 21 days.

Results. Of 408 randomized children who received the study drug (oseltamivir, 203, and placebo, 205), 98 had laboratory-confirmed influenza (influenza A, 79, and influenza B, 19). When started within 12 hours of the onset of symptoms, oseltamivir decreased the incidence of acute otitis media by 85% (95% confidence interval, 25%–97%), but no significant reduction was observed with treatment started within 24 hours. Among children with influenza A, oseltamivir treatment started within 24 hours shortened the median time to resolution of illness by 3.5 days (3.0 vs 6.5 days; P = .002) in all children and by 4.0 days (3.4 vs 7.3; P = .006) in unvaccinated children and reduced parental work absenteeism by 3.0 days. No efficacy was demonstrated against influenza B infections.

Conclusions. Oseltamivir treatment started within 24 hours of symptom onset provides substantial benefits to children with influenza A infection.

Clinical trials registration. ClinicalTrials.gov identifier: NCT00593502.

Journal Article.  4317 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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