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. Published by Elsevier B.V.
RCT Entities:
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. Published by Elsevier B.V.
Authors: Sudhir Venkatesan; Puja R Myles; Kirsty J Bolton; Stella G Muthuri; Tarig Al Khuwaitir; Ashish P Anovadiya; Eduardo Azziz-Baumgartner; Tahar Bajjou; Matteo Bassetti; Bojana Beovic; Barbara Bertisch; Isabelle Bonmarin; Robert Booy; Victor H Borja-Aburto; Heinz Burgmann; Bin Cao; Jordi Carratala; Tserendorj Chinbayar; Catia Cilloniz; Justin T Denholm; Samuel R Dominguez; Pericles A D Duarte; Gal Dubnov-Raz; Sergio Fanella; Zhancheng Gao; Patrick Gérardin; Maddalena Giannella; Sophie Gubbels; Jethro Herberg; Anjarath Lorena Higuera Iglesias; Peter H Hoeger; Xiao Yun Hu; Quazi T Islam; Mirela F Jiménez; Gerben Keijzers; Hossein Khalili; Gabriela Kusznierz; Ilija Kuzman; Eduard Langenegger; Kamran B Lankarani; Yee-Sin Leo; Romina P Libster; Rita Linko; Faris Madanat; Efstratios Maltezos; Abdullah Mamun; Toshie Manabe; Gokhan Metan; Auksė Mickiene; Dragan Mikić; Kristin G I Mohn; Maria E Oliva; Mehpare Ozkan; Dhruv Parekh; Mical Paul; Barbara A Rath; Samir Refaey; Alejandro H Rodríguez; Bunyamin Sertogullarindan; Joanna Skręt-Magierło; Ayper Somer; Ewa Talarek; Julian W Tang; Kelvin To; Dat Tran; Timothy M Uyeki; Wendy Vaudry; Tjasa Vidmar; Paul Zarogoulidis; Jonathan S Nguyen-Van-Tam Journal: J Infect Dis Date: 2020-01-14 Impact factor: 5.226