A RANDOMIZED TRIAL OF ARTESUNATE–SULFAMETHOXYPYRAZINE–PYRIMETHAMINE VERSUS ARTEMETHER–LUMEFANTRINE FOR THE TREATMENT OF UNCOMPLICATED PLASMODIUM FALCIPARUM MALARIA IN MALI

The choice of artemisinin-based combination that is being adopted for malaria treatment in sub-Saharan Africa may depend on several factors, including cost, efficacy, side effects, and simplicity of administration. We tested the hypothesis that artesunate-sulfamethoxypyrazine-pyrimethamine is as efficacious as the four-dose regimen of ar- temether-lumefantrine for treatment of Plasmodium falciparum malaria. The study was carried out during two trans- mission seasons (2003 and 2004) in Sotuba, Mali. Participants at least 6 months of age with uncomplicated P. falciparum malaria were randomly assigned to receive artesunate-sulfamethoxypyrazine-pyrimethamine or artemether- lumefantrine. Treatment efficacy was assessed using the World Health Organization 28-day protocol. A total of 606 (303 in each arm) patients were enrolled. The cure rate was higher for artesunate-sulfamethoxypyrazine-pyrimethamine than for artemether-lumefantrine (98.7% versus 89.6%; P < 0.0001). After correction for cases of re-infection, the cure rates were 100% and 99.0%, respectively (P 0.08). No serious adverse events occurred. Artesunate-sulfamethoxypyrazine- pyrimethamine is well-tolerated and effective against P. falciparum malaria. It showed an additional benefit of prevent- ing new infections.