ABSTRACT
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.
