RANDOMIZED CONTROLLED TRIAL OF ARTEMETHER BENFLUMETOL, A NEW ANTIMALARIAL AND PYRIMETHAMINE/SULFADOXINE IN THE TREATMENT OF UNCOMPLICATED FALCIPARUM-MALARIA IN AFRICAN CHILDREN/

We report here the results of a randomized double blind trial comparin g coartemether (CGP56697), a combination of artemether and benflumetol , with pyrimethamine/sulfadoxine (P/S). Two hundred eighty-seven child ren 1-5 years of age with uncomplicated falciparum malaria were enroll ed at two centers in The Gambia between July 1996 and December 1996. F ollowing treatment, children were visited at home every 24 hr until a blood him free of asexual parasites was obtained. Genotyping of parasi tes was used to distinguish recrudescence from new infections. Three d ays after the start of treatment, 133 (100%) of the CGP56697-treated c hildren compared with 128 (93.4%) of children treated with P/S had cle ared their parasites (P = 0.003). The day 15 cure rate was 93.3% for C GP56697 and 97.7% for P/S (P = 0.13). Within the third and fourth week after initiation of therapy, 20 children treated with CGP56697 and on e of the P/S-treated children returned with second malaria episodes (P < 0.0001). Genotyping suggested that the majority (19 of 23 [82.6%]) of these second episodes were due to new infections, supporting the Wo rld Health Organization recommendation that longer follow-up is not re levant for the assessment of drug efficacy. At the two-week follow-up, 28.9% of the P/S treated children but none of the CGP56697-treated ch ildren carried gametocytes (P < 0.0001). This study showed that CGP566 97 is safe in African children with acute uncomplicated falciparum mal aria, clears parasites more rapidly than P/S, and results in fewer gam etocyte carriers. More frequent new infections within the third and fo urth week following treatment with CGP56697 than treatment with P/S ar e likely to be due to the short prophylactic effect of CGP56597.