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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Uncomplicated P. Falciparum Malaria in Children

Intervention / Treatment
-----------------
* Drug: Artesunate-amodiaquine
* Drug: Artemether-lumefantrine


Participation Criteria
=================
Eligibility 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;

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artemether -lumefantrine<br>Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso | Drug: Artemether-lumefantrine<br>* 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.<br>* Other names: AL, Coartem(R), Riamet(R);|
| Experimental: Artesunate-amodiaquine<br>Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso | Drug: Artesunate-amodiaquine<br>* 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)<br>* Other names: ASAQ, Coarsucam;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polymerase chain reaction (PCR) adjusted treatment failure |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure up to day 42 (PCR adjusted and unadjusted) |  | Day 42 | 
| Gametocytes (prevalence and density) |  | At day 7, 14, 21, 28, 35 and 42 days after treatment | 
| Hb changes |  | Day 35 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uncomplicated malaria