Early oseltamivir treatment of influenza in children 1-3 years of age: a randomized controlled trial.
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 = .006) 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.
Heinonen
Santtu
S
Departments of Pediatrics, Turku University Hospital, University of Turku, Turku, Finland.
Silvennoinen
Heli
H
Lehtinen
Pasi
P
Vainionpää
Raija
R
Vahlberg
Tero
T
Ziegler
Thedi
T
Ikonen
Niina
N
Puhakka
Tuomo
T
Heikkinen
Terho
T
D000284:Administration, Oral; D000998:Antiviral Agents / Q000008:administration & dosage*; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007223:Infant; D007251:Influenza, Human / Q000188:drug therapy*; D008297:Male; D053139:Oseltamivir / Q000008:administration & dosage*; D010919:Placebos / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
D000998:Antiviral Agents; D010919:Placebos; D053139:Oseltamivir