A randomized, double-blind, parallel-group, comparative safety, and efficacy trial of oral co-artemether versus oral chloroquine in the treatment of acute uncomplicated Plasmodium falciparum malaria in adults in India.

In India, treatment of acute, uncomplicated Plasmodium falciparum malaria i s becoming increasingly difficult due to resistance to chloroquine, thus th ere is a need for new antimalarial drugs. CGP 56697 (co-artemether), a new drug, is a combination of artemether and lumefantrine in a single oral form ulation tone tablet = 20 mg of artemether plus 120 mg of lumefantrine). In a double-blind study, 179 patients with acute uncomplicated P. falciparum m alaria were randomly assigned to receive either CGP (n = 89) given as a sho rt course of 4 x 4 tablets over a 48-hr period or chloroquine (n = 90) give n as four tablets tone tablet = 150 mg of chloroquine base) initially, foll owed by two tablets each at 6-8, 24, and 48 hr. Due to a death in the chlor oquine group and a decrease in the chloroquine cure rate to < 50% (based on the blinded overall cure rate at that time), recruitment was terminated pr ematurely. CGP 56697 showed a superior 28-day cure rate (95.4% versus 19.7% ; P < 0.001), time to parasite clearance (median = 36 versus 60 hr; P < 0.0 01), and resolution of fever (median = 18 versus 27 hr; P = 0.0456). This d rug provides a safe, effective, and rapid therapy for the treatment of acut e uncomplicated P. falciparum malaria.