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 (ACTE)

NCT01017770 Phase 4 COMPLETED

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.

Details

Lead sponsor	Centre Muraz
Phase	Phase 4
Status	COMPLETED
Enrolment	340
Start date	2008-09
Completion	2010-08

Conditions

• Uncomplicated P. Falciparum Malaria in Children

Interventions

• Artesunate-amodiaquine
• Artemether-lumefantrine

Primary outcomes

• Polymerase chain reaction (PCR) adjusted treatment failure — Day 28

Countries

Burkina Faso