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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 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.

Received April 1, 2006. Accepted for publication June 12, 2006.

Acknowledgments: We are grateful to all study subjects for participating in this study; the staff of the Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy and Odonto-Stomatology, University of Bamako, Mali, for developing the protocol and for providing the team and for logistical support; Dr. David Diemert (Malaria Vaccine Development Branch, National Institutes of Health, USA) for his help obtaining reagents for laboratory analyses and for reviewing the manuscript; Kerry Wright Aradhya and Dr. Kenneth Schulz (Family Health International, Research Triangle Park, North Carolina, USA) for their thoughtful insights and for reviewing the manuscript.

Financial support: This study was supported by Dafra Pharma (Turnhout, Belgium). Dafra Pharma also donated the AS plus SMP used in the study.

Disclosure: Herwig F. Jansen is an employee of Dafra Pharma.

^* Address correspondence to Ogobara 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{at}mrtcbko.org

Authors’ addressees: Issaka Sagara, Alassane Dicko, Abdoulaye Djimde, Ousmane Guindo, Mamady Kone, Youssouf Tolo, Mahamadou A. Thera, Moussa Sogoba, Moussa Fofana, Amed Ouattara, Mady Sissoko, and 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, Telephone 223-222-8109, Fax: 223-222-4987, E-mails: isagara{at}mrtcbko.org, adicko{at}mrtcbko.org, adjimde{at}mrtcbko.org, guindoous{at}mrtcbko.org, tolo{at}mrtcbko.org, mthera{at}mrtcbko.org, msogoba{at}mrtcbko.org, moussaf{at}mrtcbko.org, amed{at}mrtcbko.org, mady{at}mrtcbko.org, and okd{at}mrtcbko.org. Herwig F. Jansen, Dafra Pharma, NV Slachthuisstraat 30/7, 2300 Turnhout, Belgium, Telephone: 32-1-461-7820, Fax: 32-1-461-7859, E-mail: fhj{at}dafra.be.

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{at}mrtcbko.org.

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