A comparison of the Efficacy of Artesunate Plus Sulfadoxine–Pyrimethamine with that of Sulfadoxine– Pyrimethamine Alone, in the Treatment of Uncomplicated, Plasmodium Falciparum Malaria in Eastern Sudan

Abstract

In an open, randomized, clinical trial, conducted in New Halfa, eastern Sudan in September–October 2004, the efficacies and adverse effects of artesunate plus sulfadoxine–pyrimethamine (SP), in the treatment of uncomplicated, Plasmodium falciparum malaria, were compared with those of SP alone. Patients were randomized to receive either artesunate (4 mg/kg.day) on days 0–2 plus SP (25 mg sulfadoxine/kg) on day 0 or the SP alone, and then followed-up for 28 days. Sixty patients completed follow-up. Compared with the 30 given artesunate plus SP (ASP), the 30 given SP alone were much more likely to be febrile (30% v. 3.3%; P50.006) and parasitaemic (50% v. 6.7%; P,00001) on day 1. By day 3, 16.7% of the patients given SP alone were still febrile and 6.7% of them were still parasitaemic, although all the patients given ASP were then afebrile (P50.02) and aparasitaemic (P50.1). Five (16.7%) of the patients treated with SP alone but none of those given ASP appeared to be treatment failures (P,0.05). Parasite genotyping revealed that four of the five apparent treatment failures were true recrudescences but the other represented a re-infection detected on day 28. The true frequencies of cure by day 28 were therefore 100% for ASP and 86.7% for SP alone (P50.02). Adverse effects of treatment (nausea, itching and giddiness) were observed with similar frequencies in the two treatment arms (10.0% of the patients given ASP v. 13.3% of the patients given SP alone; P.0.05). The frequencies of gametocytaemia during follow-up were, however, much lower in the ASP arm than in the SP-only (0.0% v. 23.3%; P50.005). Thus, although the problems posed by adverse effects were similar in the two treatment arms, ASP appeared markedly better, in terms of fever- and parasite-clearance times and the prevalence of post-treatment gametocytaemia, than SP alone.