ACTs are effective and today are considered by World Health Organization to be the best anti-malarials in terms of efficacy and a lower propensity to resistance. However, resistance to the recommended anti-malarial drugs has become a challenge and is a public health problem. Efforts are required to secure new therapies (single or in combination), which could be an alternative to standard treatment.

The combination of AS and MQ, whether in loose or fixed combination, was the first of the artemisinin-based combinations, used extensively in Asia and Latin America, however there is very limited data on its efficacy and safety in young children in Africa.  ASMQ has a simple schedule of administration with single daily doses of one to two tablets per day according to an age-based categories, rather than weight. It is available on paediatric formulation and field-adapted packaging with 3 years of stability.

 The proposed study will evaluate a new product, Farmanguinhos Artesunate-Mefloquine, a fixed-dosed combination of Artesunate-Mefloquine in the treatment of uncomplicated P. falciparum malaria and will also add to the scarce knowledge on efficacy, safety and pharmacokinetics of the combination in young children in Africa.  The target population in the study is under-5 children, the primary victims of malaria in the continent, with the highest burden of the disease, and which had been documented to have increased rates of vomiting with mefloquine monotherapy