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Formulación pediátrica de artesunato y mefloquina versus artemeter‐lumefantrina para el tratamiento de la malaria no complicada por Plasmodium falciparum en Anonkoua kouté, Costa de Marfil
Author(s) -
Toure Offianan A.,
Kouame Menan G.,
Didier Yapi J.,
Berenger Ako A. A.,
Djerea Khali,
Genevieve Gomez O.,
Penali Louis K.
Publication year - 2011
Publication title -
tropical medicine and international health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.056
H-Index - 114
eISSN - 1365-3156
pISSN - 1360-2276
DOI - 10.1111/j.1365-3156.2010.02701.x
Subject(s) - artemether/lumefantrine , medicine , artesunate , artemether , malaria , mefloquine , plasmodium falciparum , lumefantrine , population , clinical endpoint , randomized controlled trial , cote d ivoire , surgery , gastroenterology , artemisinin , immunology , environmental health , philosophy , humanities
Summary Objectives To test the hypothesis that Artesunate–mefloquine paediatric (AS+MEF) is as effective as Artemether–lumefantrine (AL) in treating acute uncomplicated malaria in children. Methods In an open label, randomized controlled clinical trial, children aged 6–59 months were randomized to receive AS+MEF or AL. Both drug regimens were given for 3 days, and follow‐up was for 28 days. The primary endpoint was the 28‐day cure rate and was defined as proportion of patients with PCR‐corrected cure rate after 28 days of follow‐up. Results One hundred and fifty‐six patients with confirmed uncomplicated P. falciparum malaria were randomly assigned to receive AS+MEF ( n = 77) or AL ( n = 79). PCR‐corrected day 28 cure rates for per protocol (PP) populations were 99% for AS+MEF and 97% ( P = 1) for AL. For the intention to treat (ITT) population, cure rates were 96% for AS+MEF and 92% ( P = 0.49) for AL. Both regimens were well tolerated. Conclusion AS+MEF is as effective as AL, and both combinations were efficacious and safe.