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.
Sagara
Issaka
I
Malaria Research and Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy, and Odonto-Stomatology, University of Bamako, Bamako, Mali. isagara@mrtcbko.org
Dicko
Alassane
A
Djimde
Abdoulaye
A
Guindo
Ousmane
O
Kone
Mamady
M
Tolo
Youssouf
Y
Thera
Mahamadou A
MA
Sogoba
Moussa
M
Fofana
Moussa
M
Ouattara
Amed
A
Sissoko
Mady
M
Jansen
Herwig F
HF
Doumbo
Ogobara K
OK
D000293:Adolescent; D000328:Adult; D000740:Anemia / Q000517:prevention & control; D000962:Antimalarials / Q000009:adverse effects / Q000627:therapeutic use*; D000077549:Artemether; D037621:Artemisinins / Q000009:adverse effects / Q000627:therapeutic use*; D000077332:Artesunate; D002353:Carrier State / Q000188:drug therapy; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005449:Fluorenes / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007223:Infant; D000078102:Lumefantrine; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011739:Pyrimethamine / Q000009:adverse effects / Q000627:therapeutic use*; D012717:Sesquiterpenes / Q000009:adverse effects / Q000627:therapeutic use*; D013415:Sulfalene / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; D012717:Sesquiterpenes; D000077332:Artesunate; D000077549:Artemether; D000078102:Lumefantrine; D013415:Sulfalene; D011739:Pyrimethamine