Efficacy of artesunate plus pyrimethamine-sulphadoxine for uncomplicated malaria in Gambian children: a double-blind, randomised, controlled trial

This double-blind, randomized, controlled study investigated the efficacy, safety and tolerability of artesunate plus pyrimethamine-sulphadoxine for uncomplicated malaria among Gambian children. Combined use of artesunate and pyrimethamine-sulphadoxine was hypothesized to delay or prevent resistance, which proved to be effective in reducing childhood mortality in sub-Saharan Africa. A total of 600 children with acute uncomplicated Plasmodium falciparum malaria, 6 months to 10 years old, were randomly administered pyrimethamine-sulphadoxine (25 mg/500 mg) with placebo, 4 mg/kg body weight pyrimethamine-sulphadoxine plus 1 dose of artesunate, or pyrimethamine-sulphadoxine plus 4 mg/kg body weight artesunate for 3 days. Results indicate that combined treatment was well tolerated. On day 1, 178 of 381 children treated with artesunate were still parasitemic compared with 157 of 195 children in the pyrimethamine-sulphadoxine group. On the other hand, failure rates on day 14 were 3.1% in the pyrimethamine-sulphadoxine group and 3.7% in the 1-dose artesunate group and 1.6% in the 3-dose group. Insignificant differences were found among children administered 1-dose and 3-dose artesunate, and were found less likely to be gametocytemic after treatment. In conclusion, this study confirms the safety and efficacy of a combined treatment, which eventually results in lower gametocyte rates and lower transmission rates.