RESUMO
BACKGROUND: Although artesunate and mefloquine have been used as monotherapies in the treatment of malaria in Kenya for a long time, there is insufficient data on the clinical outcome when used as combination therapy in this population. OBJECTIVE: To derive data on the efficacy and safety profile of artesunate-mefloquine combination in the treatment of uncomplicated Plasmodium falciparum malaria in Kenya. DESIGN: An open label single arm clinical trial. SETTING: Bungoma district Hospital. Study area was Bungoma District of Kenya, an endemic area of malaria. The study was conducted between January 2004 and April 2004. SUBJECTS: A total of 200 males and females with uncomplicated plasmodium falciparum malaria weighing 35kg and above were recruited in the study. RESULTS: In the evaluable patient population the day 28 cure rate was 98.4% while day 14 and 7 cure rates were 98.4% and 99.2% respectively. There was rapid relief of symptoms the median time of fever clearance was one day and the most common drug related adverse events were headache dizziness and asthenia. There was no significant derangement in the haematological, biochemical and ECG parameters in the patients on treatment. CONCLUSION: Artesunate-mefloquine combination given simultaneously was found to be highly effective and safe in the treatment of uncomplicated malaria.