A randomized, double-blind, comparative trial of a new oral combination ofartemether and benflumetol (CGP 56697) with mefloquine in the treatment ofacute Plasmodium falciparum malaria in Thailand

CGP 56697, a new oral fixed combination of artemether and benflumetol, was tested in a double-blinded, randomized trial in 252 adult patients treated either with CGP 56697 (4 x 4 tablets each containing 20 mg of artemether an d 120 mg of benflumetol, given at 0, 8, 24, and 48 hr), or with mefloquine (three tablets of 250 mg at initial diagnosis, followed by two tablets of 2 50 mg at 8 hr). Baseline data of the two groups were comparable. The 28-day cure rate with CGP 56697 was lower than with mefloquine (69.3% versus 82.4 %; P = 0.002). However, CGP 56697 was more effective than mefloquine in par asite clearance time (43 hr versus 66 hr; P < 0.001) fever clearance time ( 32 hr versus 54 hr; P < 0.005), and gametocyte clearance time (152 hr versu s 331 hr; P < 0.001). This study revealed that CGP 56697 is effective again st multidrug-resistant Plasmodium falciparum malaria in Thailand, but highe r doses will probably be needed to improve the cure rare.