Efficacy of Artesunate + Amodiaquine Versus Artemether-lumefantrine for Falciparum Malaria in Zanzibar, 2005
Status:
Completed
Trial end date:
2005-07-11
Target enrollment:
Participant gender:
Summary
The primary objective of the study was to determine the PCR-APCR up to day 42 in children <60
months of age, weighing ≥5kg with uncomplicated malaria, treated with either artesunate+
amodiaquine (ASAQ) or artemether-lumefantrine (AL; Coartem®).
Secondary objectives included: clinical and laboratory assessment of drug tolerability and
safety, evaluation of possible correlation between drug bioavailability and clinical outcome,
comparison of efficacy data with the pre-implementation "ACO I" study, parasite and fever
clearance, gametocyte carriage, and possible selection of mutations related to quinoline
resistance.