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Antiviral Res ; 133: 85-94, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27451343

RESUMO

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.


Assuntos
Antivirais/uso terapêutico , Influenza Humana/tratamento farmacológico , Oseltamivir/uso terapêutico , Antivirais/administração & dosagem , Antivirais/efeitos adversos , Criança , Pré-Escolar , Comorbidade , El Salvador , Feminino , Hospitalização , Humanos , Lactente , Recém-Nascido , Influenza Humana/diagnóstico , Influenza Humana/virologia , Tempo de Internação , Masculino , Oseltamivir/administração & dosagem , Oseltamivir/efeitos adversos , Panamá , Índice de Gravidade de Doença , Resultado do Tratamento
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