NCT01017770

Artemether-lumefantrine (AL) Versus Artesunate + Amodiaquine (ASAQ) for the Treatment of Uncomplicated Falciparum Malaria in Burkina Faso

Artemether-lumefantrine Vs Co-formulated Amodiaquine + Artesunate for the Treatment of Uncomplicated Falciparum Malaria: a Randomized Open-label Trial to Evaluate the Effectiveness of the Burkina Faso New Drug Policy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 340 (estimated)
• Sponsor: Centre Muraz · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

Summary

Several countries in Africa have changed their first-line treatment for uncomplicated malaria to an ACT. Burkina Faso has changed its policy to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, such choice has been done without knowing the local effectiveness of these drugs when they are given to patients in real life conditions, without direct observation of the drug administration. Thus, this study aims at investigating the effectiveness of AQ+AS and AL, when given to children with uncomplicated malaria in Burkina Faso.

Conditions

• Uncomplicated P. Falciparum Malaria in Children

Interventions

Type	Name	Description
DRUG	Artesunate-amodiaquine	Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)
DRUG	Artemether-lumefantrine	Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing \> 35 kg.

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-01-01
• Completion: 2010-08-01
• First posted: 2009-11-23
• Last updated: 2015-07-31

Locations

4 sites across 1 country: Burkina Faso