EFFICACY AND SAFETY OF CGP-56697 (ARTEMETHER AND BENFLUMETOL) COMPARED WITH CHLOROQUINE TO TREAT ACUTE FALCIPARUM-MALARIA IN TANZANIAN CHILDREN AGED 1-5 YEARS

A randomized, open trial involving 260 Tanzanian children, aged 1-5 ye ars, with acute Plasmodium falciparum malaria was conducted to evaluat e the efficacy of the combination antimalarial CGP 56697 (artemether a nd benflumetol), and to compare it with chloroquine the standard drug used for malaria treatment in the Kilombero area. Children who had rec eived rescue medication within the first 48 h or had a negative slide at the same time were excluded. Seven-day parasitological cute rates M ere 94% (95% CI 88-97.5) for CGP 56697 and 35.4% (95% CI 25.9-45.8) fo r chloroquine. Using the same definition, the 14-day parasitological c ure rates were 86.4% (95% CI 78.5-92.2) for CGP 56697; and 10.3% (95% CI 5.1-18.1) for chloroquine. Gametocytes were more effectively suppre ssed by CGP 56697 than by chloroquine. There were no major adverse eve nts with either drug. CGP 56697 is highly efficacious against P. falci parum in this area of Tanzania. The study contributes to the discussio n on treatment strategies, particularly whether chloroquine may still fulfil its role as first-line drug in an area of high malaria transmis sion and very high levels of chloroquine resistance.