Uncomplicated Malaria Clinical Trial
Official title:
Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study
Malaria is a life-threatening disease especially in small children. A high degree of
Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this
study is taking place. In the past few years, the recommendation for a first-line treatment
in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing
evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the
study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT):
artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be
unsupervised.
The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary
outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the
relationships between ACT PK data (day 3) and outcome.
Expected total enrollment: 225 patients
Study start: April 2007; expected completion: December 2007
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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