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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,390
Cameroon Baptist Convention Clinic of Biyem-Assi
Yaoundé, Cameroon
Health centres of Samako, Kolle and Bancoumane
Bamako, Mali
Health centres Rwamagana and Muhima
Kigali, Rwanda
Alhara Alola Health centre
New Halfa, Sudan
PCR corrected Adequate Clinical and Parasitological Response
Time frame: on day 28 (follow-up period)
Early treatment failure
Time frame: between day 0 and day 3
Late clinical failure
Time frame: between day 4 and day 28
Late parasitological failure
Time frame: between day 7 and day 28
Parasitic clearance
Time frame: 28 day follow-up period
Fever clearance
Time frame: 28 day follow-up period
Parasitological re-infection
Time frame: 28 day follow-up period
Gametocyte carriage
Time frame: 28 day follow-up period
Safety - Adverse events
Time frame: 28 day follow-up period
Haemoglobin levels
Time frame: 28 day follow-up period
Clinical and biological tolerance (Haemogram + Lever tests)
Time frame: 28 day follow-up period
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