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QUESTION: In Gambian children with acute uncomplicated malaria, is pyrimethamine sulfadoxine (PS) and artesunate more effective than PS alone for Plasmodium falciparum malaria?
Design
Randomised (allocation concealed*), blinded (patients, parents, and investigators),* placebo controlled trial with 28 day follow up.
Setting
5 health centres in the Gambia (1 in a semiurban coastal area and 4 in the rural inland region).
Patients
600 children who were <10 years of age (mean age 5 y, 52% boys), weighed >5 kg, were infected with P. falciparum at a density of ≥500/μl, had a history of fever, and lived within 20 km of a trial centre. Exclusion criteria were requirement for parenteral treatment, treatment within the previous 2 weeks with PS, a haematocrit concentration …