Double-blind dose finding study of mefloquine-sulfadoxine-pyrimethamine in children with acute falciparum malaria.

Three different doses of a combination of mefloquine-sulfadoxine-pyrimethamine (MSP), given double-blind as a single dose to 60 children, were evaluated for efficacy and tolerance. The children, 42 boys and 18 girls aged between 5 and 15 years, received a mefloquine dose equivalent to 1, 1.5, or 2 standard MSP (Fansimef) tablets. Radical cure was obtained in all patients with only mild to moderate side effects of nausea and vomiting, which were not worse in the higher dose groups. For children living in an endemic malarious area, a single dose of mefloquine 7.1-12.5 mg/kg, given in combination with sulfadoxine (14.3-25.0 mg/kg) and pyrimethamine (0.7-1.3 mg/kg), is a safe and effective treatment for uncomplicated chloroquine-resistant Plasmodium falciparum malaria. This dose of MSP is approximately 10 mg/kg, 20 mg/kg and 1.0 mg/kg respectively of mefloquine, sulfadoxine and pyrimethamine, which is equivalent to a single standard tablet of Fansimef (mefloquine, 250 mg; sulfadoxine, 500 mg; pyrimethamine, 25 mg) given to a child weighing 20-30 kg.