A safety and efficacy trial of artesunate, sulphadoxine-pyrimethamine and primaquine in P falciparum malaria.

OBJECTIVE To determine effectiveness and safety of the combination of artesunate, sulphadoxine + pyrimethamine and primaquine in the treatment of P falciparum malaria. DESIGN A hospital based prospective study. SETTING Base Hospital, Moneragala. METHODS In 30 P falciparum infected patients admitted to the hospital, blood was taken for estimation of haemoglobin, white cell counts, and serum levels of aspartate aminotransferase, alanine aminotransferase, bilirubin and creatinine. They were administered artesunate, sulphadoxine + pyrimethamine (S + P) and primaquine on day 0 (artesunate 4 mg/kg, sulphadoxine 25 mg/kg, pyrimethamine 1.25 mg/kg and primaquine 0.75 mg/kg), and only artesunate on days 1 and 2 (artesunate 4 mg/kg each day). Blood was examined for malarial parasites, and patients were assessed on days 1, 2, 7, 14, 21 and 28. Patients assessed the severity of selected symptoms. Biochemical analyses were done on day 0 and repeated on days 7 and 28. RESULTS Eight patients presented with fever which resolved in 7 patients in 48 hours. Asexual parasites were cleared in 80% of the 30 patients within 24 hours of treatment and in all 30 by day 7. Gametocytaemia cleared in all patients by day 14. There were no adverse effects experienced by the patients. The white cell and differential counts, liver enzymes and creatinine levels were within normal limits on all follow up days. CONCLUSIONS The combination of artesunate, S + P and primaquine was found to be effective and safe in the treatment of uncomplicated P falciparum malaria.