EFFICACY OF RO-42-1611 (ARTEFLENE) IN THE TREATMENT OF PATIENTS WITH MILD MALARIA - A CLINICAL-TRIAL IN CAMEROON

The novel antimalarial Ro 42-1611 (arteflene) was evaluated for safety and efficacy in an open, non-comparative study of patients with mild malaria in the south of Cameroon. Thirty male patients aged 12 to 42 y ears, with an initial Plasmodium falciparum count of > 5000 (mean: 21, 406) parasites/mu l and a body temperature of 37.7 % to 39.8 degrees C , were selected to receive a single dose of arteflene, corresponding t o 25 +/- 2.5 mg/kg bodyweight. Efficacy was assessed at 6, 9, 12, 24, 36, 48 and 72 hours, and at seven days by: reduction in parasitaemia a nd time to parasite clearance; resolution of fever and clinical cure ( defined as the absence of signs and symptoms of malaria). Adverse even ts were reported at baseline and at each assessment point, and laborat ory tests were carried out at 2 and 7 days. The mean number of parasit es/mu l fell from 21,406 at baseline to 157 after 48 hours, at which p oint 80 % of patients were completely free of parasites. Mean body tem perature was reduced from 38.9 degrees C at baseline to 37.3 degrees C 12 hours after arteflene administration, and by this time 80 % of pat ients had a normal temperature. Clinical cure rates were also high, wi th 70 % of patients free of all signs and symptoms after 24 hours. How ever, by day 7, 6/30 (20 %) presented with smears positive for P. falc iparum. There were no adverse events considered to be related to treat ment. A single dose of 25 mg/kg arteflene was found to be an effective and well-tolerated treatment for mild P. falciparum malaria.