Comparative clinical trial of artesunate suppositories and oral artesunate in combination with mefloquine in the treatment of children with acute falciparum malaria.

A randomized pilot study to compare the safety and efficacy of artesunate suppositories (15 mg/kg/day for three days) versus oral artesunate (6 mg/kg/day for three days), both in combination with mefloquine (25 mg/kg), was conducted in 52 Thai children with uncomplicated multidrug-resistant falciparum malaria. Forty-five patients (87%) had a full 28-day follow-up in the hospital to assess efficacy and exclude reinfection. Mean (range) times to fever clearance of the two groups were similar (42 hr (15-104) versus 42 hr (6-119)). Artesunate suppositories resulted in significantly longer times to achieve 50% and 90% reductions of the initial parasite counts (17 and 26 hr versus 9 and 15 hr; P , 0.05 and P , 0.001). Time (range) to parasite clearance was longer in the artesunate suppositories group (42 hr (14-93) versus 35 hr (16-69)), but the difference was not significant. The cure rates by days 28 were not significantly different, 92% for artesunate suppository-treated patients and 100% for oral artesunate- treated patients. Both drug regimens are safe and effective. Further studies are needed to characterize the pharma- cokinetic properties and the optimum regimen of artesunate suppositories for the treatment of severe malaria.