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

Muraz Center

Status and phase

Completed

Phase 4

Conditions

Uncomplicated P. Falciparum Malaria in Children

Treatments

Drug: Artesunate-amodiaquine

Drug: Artemether-lumefantrine

Study type

Interventional

Funder types

Other

Identifiers

NCT01017770

ACTEffectiveness

Details and patient eligibility

About

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.

Enrollment

340 estimated patients

Sex

All

Ages

6 to 59 months old

Volunteers

No Healthy Volunteers

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;