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

ISSAKA SAGARA Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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ALASSANE DICKO Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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ABDOULAYE DJIMDE Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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OUSMANE GUINDO Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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MAMADY KONE Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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YOUSSOUF TOLO Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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MAHAMADOU A. THERA Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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MOUSSA SOGOBA Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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MOUSSA FOFANA Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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AMED OUATTARA Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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MADY SISSOKO Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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HERWIG F. JANSEN Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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OGOBARA K. DOUMBO Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali; Dafra Pharma, Turnhout, Belgium

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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 artemether–lumefantrine for treatment of Plasmodium falciparum malaria. The study was carried out during two transmission 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 preventing new infections.

Author Notes

Reprint requests: Ogobara K. Doumbo, Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-stomatology, University of Bamako PO Box 1805, Point G, Bamako, Mali. E-mail: okd@mrtcbko.org.
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