COMPARATIVE CLINICAL-TRIAL OF ARTESUNATE SUPPOSITORIES AND ORAL ARTESUNATE IN COMBINATION WITH MEFLOQUINE LN THE TREATMENT OF CHILDREN WITHACUTE FALCIPARUM-MALARIA

A randomized pilot study to compare the safety and efficacy of artesun ate 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 multidru g-resistant falciparum malaria. Forty-five patients (87%) had a full 2 8-day follow-up in the hospital to assess efficacy and exclude reinfec tion. Mean [range] times to fever clearance of the two groups were sim ilar (42 hr [15-104] versus 42 hr [6-119]). Artesunate suppositories r esulted in significantly longer times to achieve 50% and 90% reduction s 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-treat ed patients and 100% for oral artesunate-treated patients. Both drug r egimens are safe and effective. Further studies are needed to characte rize the pharmacokinetic properties and the optimum regimen of artesun ate suppositories for the treatment of severe malaria.