NCT00460369

Treatment of Uncomplicated Malaria in Benin

Sulfadoxine-Pyrimethamine Versus Artemether-Lumefantrine Versus Amodiaquine-Artesunate Coformulation in Uncomplicated Plasmodium Falciparum Malaria : an Open Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Institut de Recherche pour le Developpement · Other Government
• Sex: All
• Age: 6 Months – 119 Months
• Healthy volunteers: Not accepted

Summary

Malaria is a life-threatening disease especially in small children. A high degree of Plasmodium falciparum resistance to chloroquine has already spread to South-Benin where this study is taking place. In the past few years, the recommendation for a first-line treatment in this area has moved from chloroquine to sulfadoxine-pyrimethamine (SP). There is growing evidence that Plasmodium falciparum resistance to SP has come to South-Benin. The aim of the study is to compare the efficacy of SP to two compact artemisinin-based therapies (ACT): artemether-lumefantrine and the amodiaquine-artesunate coformulation. ACT will be unsupervised. The primary endpoint is an effectiveness comparison (PCR corrected) at day 28. Secondary outcomes are effectiveness comparisons (PCR corrected) at day 14 and 42 and a study on the relationships between ACT PK data (day 3) and outcome. Expected total enrollment: 225 patients Study start: April 2007; expected completion: December 2007

Conditions

• Uncomplicated Malaria

Interventions

Type	Name	Description
DRUG	sulfadoxine-pyrimethamine	tablets 1,25/25 mg 1 tablet per 20 kg of body weight Single drug intake
DRUG	artemether-lumefantrine	tablets 20/120 mg * 1 tablet twice daily for 3 days below 15 kg of bodyweight * 2 tablets twice daily for 3 days below 24 kg of bodyweight * 3 tablets twice daily for 3 days below 35 kg of bodyweight
DRUG	amodiaquine-artesunate coformulation	one 25mg/67,5mg tablet, once daily for 3 days below 9 kg one 50/135mg tablet, once daily for 3 days below 18 kg

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-04-13
• Last updated: 2008-04-14

Locations

1 site across 1 country: Benin