Oral oseltamivir treatment of influenza in children

Background. Oral oseltamivir administration is effective treatment for infl uenza in adults. This study was conducted to determine the efficacy, safety and tolerability of oseltamivir in children with influenza. Methods. In this randomized, double blind, placebo-controlled study, childr en 1 through 12 years with fever [greater than or equal to 100 degreesF (gr eater than or equal to 38 degreesC)] and a history of cough or coryza <48 h duration received oseltamivir 2 mg/kg/dose or placebo twice daily for 5 da ys. The primary efficacy endpoint was the time to resolution of illness inc luding mild/absent cough and coryza mild/absent, return to normal activity and euthermia. Results. Of 695 enrolled children 452 (65%) had influenza (placebo, n = 235 ; oseltamivir, n = 217), Among infected children the median duration of ill ness was reduced by 36 h (26%) in oseltamivir compared with placebo recipie nts (101 h; 95% confidence interval, 89 to 118 vs. 137 h; 95% confidence in terval, 125 to 150; P < 0,0001), Oseltamivir treatment also reduced cough, coryza and duration of fever. New diagnoses of otitis media were reduced by 44% (12% vs. 21%), The incidence of physician-prescribed antibiotics was s ignificantly lower in influenza-infected oseltamivir (68 of 217, 31%) than placebo (97 of 235, 41%; P = 0.03) recipients. Oseltamivir therapy was gene rally well-tolerated, although associated with an excess frequency of emesi s (5.8%). Discontinuation because of adverse events was low in both groups (1.8% with oseltamivir vs. 1.1% with placebo), Oseltamivir treatment did no t affect the influenza-specific antibody response. Conclusions. Oral oseltamivir administration is an efficacious and well-tol erated therapy for influenza in children when given within 48 h of onset of illness.