Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P. Falciparum Malaria

Open Randomized Multi-Centre Trial, Comparing Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 3 Days, Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 48 Hours and Artemether-Lumefantrine FDC Over 3 Days on P. Falciparum Malaria

The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine, administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunate/sulfamethoxypyrazine/pyrimethamine As/SMP fdc, independently of the duration of its dose interval, is not inferior in efficacy to 6 - 24 pills (number of pills administered to respectively children and adults)of the 60 hours treatment of artemether/lumefantrine for the treatment of uncomplicated P. falciparum malaria.

Inclusion Criteria:

• age at least 6 months,
• weight at least 5 kg,
• residing in one of the four countries (Mali, Cameroon, Sudan, Rwanda),
• able to receive oral treatment,
• having an axillary body temperature of more than 37,5 degrees Celsius or history of fever within the proceeding 24 hours,
• suffering from a mono specific P. falciparum infection with a parasite density between 2000 and 200000 asexual forms per micro litre of blood.

Exclusion Criteria:

• presence of severe or complicated malaria (WHO 2000),
• severe concomitant pathology or one that needs a medical follow-up incompatible with the study,
• allergic to one of the drugs involved in this study,
• pregnant (reported pregnancy, detected clinically or with the β HCG test),
• use of one of the anti-malaria drugs involved in this study during 28 days preceding inclusion.