Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy for Uncomplicated Malaria in Malawi
Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
Participant gender:
Summary
Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria
in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that
the drug is much less effective than in previous years. This study was developed and
conducted in collaboration with the National Malaria Control Programme of Malawi to assess
the efficacy of four antimalarial drug combinations to provide evidence to assist the
Malawian Ministry of Health in identifying and implementing as policy the next first-line
antimalarial for uncomplicated malaria in Malawi. In an open, randomized trial in children
under five years of age, four drug combinations, all of which are licensed in Malawi, are
being assessed: amodiaquine plus sulfadoxine-pyrimethamine (AQ-SP), amodiaquine plus
artesunate (AQ-Art), chlorproguanil-dapsone plus artesunate (CD-Art) and
lumefantrine-artemether (LA). SP is also included as a fifth arm of the study for current
data on its efficacy. Data on side effects of the drugs will also be collected. The results
of this study will provide some of the information necessary to guide the Malawi National
Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated
malaria. The study adheres to the World Health Organization's 2003 standardized protocol for
assessing antimalarial drug efficacy.