NCT00484900

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,390 (actual)
• Sponsor: Dafra Pharma · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
DRUG	Co-Arinate FDC
DRUG	Coartem

Timeline

• Start date: 2006-05-01
• Completion: 2007-05-01
• First posted: 2007-06-11
• Last updated: 2008-03-26

Locations

4 sites across 4 countries: Cameroon, Mali, Rwanda, Sudan