A randomized trial of artesunate-sulfamethoxypyrazine-pyrimethamine versus artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Mali

Am J Trop Med Hyg. 2006 Oct;75(4):630-6.

Abstract

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Anemia / prevention & control
  • Antimalarials / adverse effects
  • Antimalarials / therapeutic use*
  • Artemether
  • Artemisinins / adverse effects
  • Artemisinins / therapeutic use*
  • Artesunate
  • Carrier State / drug therapy
  • Child
  • Child, Preschool
  • Drug Combinations
  • Drug Therapy, Combination
  • Ethanolamines / adverse effects
  • Ethanolamines / therapeutic use
  • Female
  • Fluorenes / adverse effects
  • Fluorenes / therapeutic use
  • Humans
  • Infant
  • Lumefantrine
  • Malaria, Falciparum / drug therapy*
  • Male
  • Middle Aged
  • Pyrimethamine / adverse effects
  • Pyrimethamine / therapeutic use*
  • Sesquiterpenes / adverse effects
  • Sesquiterpenes / therapeutic use*
  • Sulfalene / adverse effects
  • Sulfalene / therapeutic use*
  • Treatment Outcome

Substances

  • Antimalarials
  • Artemisinins
  • Drug Combinations
  • Ethanolamines
  • Fluorenes
  • Sesquiterpenes
  • Artesunate
  • Artemether
  • Lumefantrine
  • Sulfalene
  • Pyrimethamine