Artesunate/mefloquine paediatric formulation vs. artemether/lumefantrine for the treatment of uncomplicated Plasmodium falciparum in Anonkoua kouté, Côte d’Ivoire
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.
Document Type: Research Article
Publication date: 2011-03-01