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

NCT00484900 Phase 3 COMPLETED

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.

Details

Lead sponsor	Dafra Pharma
Phase	Phase 3
Status	COMPLETED
Enrolment	1390
Start date	2006-05
Completion	2007-05

Conditions

• Plasmodium Falciparum Malaria

Interventions

• Co-Arinate FDC
• Coartem

Primary outcomes

• PCR corrected Adequate Clinical and Parasitological Response — on day 28 (follow-up period)
• Early treatment failure — between day 0 and day 3
• Late clinical failure — between day 4 and day 28
• Late parasitological failure — between day 7 and day 28

Countries

Cameroon, Mali, Rwanda, Sudan