A randomized, double-blind, placebo-controlled trial evaluating the safety of early oseltamivir treatment among children 0–9 years of age hospitalized with influenza in El Salvador and Panama

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Abstract

Background

Oseltamivir reduces symptom duration among children with uncomplicated influenza, but few data exist on treatment efficacy and tolerability among hospitalized children, particularly among infants aged <1 year. We evaluated tolerability and efficacy of oseltamivir treatment of children aged 0–9 years hospitalized with influenza.

Methods

We conducted a double-blind, randomized, placebo-controlled trial at tertiary care hospitals in El Salvador and Panama. Primary outcomes were length of hospitalization and increased work of breathing. Children were eligible if hospitalized <7 days after symptom onset with cough or sore throat plus tachypnea. Children were randomized 1:1 to receive oseltamivir or placebo; had swabs collected at enrollment for influenza RT-PCR testing; were assessed at enrollment and every 12 h for work of breathing; and were followed for adverse events through 7 days after discharge. Analyses were intention-to-treat.

Results

Overall, 683 children were randomized (oseltamivir, n = 341, placebo n = 342). Fifty-three percent were aged <1 year and 30 had influenza (oseltamivir, n = 19; placebo, n = 11). The study was terminated early after enrollment of 21% of the sample size due to lower than anticipated participant accrual. Using Kaplan-Meier analysis, there was no significant difference in median length of hospitalization (3 days, IQR 2–4 vs. 5 days, IQR 3–7, p = 0.22) and increased work of breathing (36 h, IQR 24–72 vs. 96 h, IQR 13–108, p = 0.14) between oseltamivir versus placebo recipients. There was no difference in adverse events between groups.

Conclusion

Oseltamivir treatment was well tolerated among hospitalized children, including among infants aged <1 year.

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