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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Muraz
• Collaborator: Institute of Tropical Medicine, Belgium
• Treatments: Amodiaquine; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine

Criteria

Inclusion Criteria:

• Weight > 5 kg;

• Monoinfection with P. falciparum and a parasitaemia of 2,000-200,000 parasites /µl;

• Fever (axillary temperature ≥37.5 °C) or history of fever in the preceding 24 hours;

• Haemoglobin value above 5.0 g/dl;

• Absence of febrile conditions caused by diseases other than malaria.

Exclusion Criteria:

• Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand;

• Signs of severe malaria (WHO 2000);

• Mixed malaria infection;

• Severe malnutrition;

• Other underlying diseases (cardiac, renal, hepatic diseases);

• History of allergy to study drugs;