Radomized clinical trials of dihydroartemisisnin - piperaquine against multi-drug resistant falciparum malaria in Viet Nam

ABSTRACT

A hospital based pilot study, conducted in a Tropical diseases hospital in Ho Chi Minh City of Viet Nam, compared the efficacy of three day regimens of dihydroartemisinin-trimethoprim-piperaquine (DTP total dose 4.7/13/47 mg/kg) with the standard antimalarial regimen in Vietnam, artersunate-mefloquine (A3M total dose 12/25 mg/kg) in non immune patients with uncomplicated falciparum malaria. 114 patients were enrolled (78 to the DTP arm and 36 to the A3M arm). The subsequent open randomised trial conducted at a Provincial Health Station compared DTP, dihydroartemisinin-piperaquine (DP) and A3M in 400 patients. In both studies all patients received derectly observed therapy and were followed for 56 days. The results: In the pilot study, the 56 day cure rate, adjusted for reinfections by PCR genotyping was 97.4% in the DTP group and 100% in the A3M group. In the second study, the cure rate were similar in each group. The DTP regimens were well tolerated, less than 3% of patients experienced possible drug related side effects compared with 16% of A3M patients