A randomized safety and tolerability trial of artesunate plus sulfadoxine-pyrimethamine versus sulfadoxine-pyrimethamine alone for the treatment of uncomplicated malaria in Gambian children

Artemisinin derivatives, such as artesunate, have a short half-life and ver y rapid anti-malarial activity. Theoretically, using such agents in conjunc tion with well-established anti-malarial drugs such as sulfadoxine-pyrimeth amine may reduce the rate of drug resistance. Such a combination has not pr eviously been used in Africa. We have conducted a pilot safety trial of art esunate (4 mg/kg for 3 days) given with a single dose of sulfadoxine-pyrime thamine (25 mg/kg sulfadoxine) compared to sulfadoxine-pyrimethamine alone among 40 Gambian children with uncomplicated malaria. Both regimens were sa fe and well tolerated and there were no adverse experiences attributed to t he combination. The addition of artesunate resulted in a higher proportion of afebrile children and children with a negative blood film on Day 2, and a reduction in the proportion of gametocyte carriers, when compared to sulf adoxine-pyrimethamine alone.