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

• Treatment failure up to day 42 (PCR adjusted and unadjusted) [ Time Frame: Day 42 ] [ Designated as safety issue: Yes ]
• Gametocytes (prevalence and density) [ Time Frame: At day 7, 14, 21, 28, 35 and 42 days after treatment ] [ Designated as safety issue: Yes ]
• Hb changes [ Time Frame: Day 35 ] [ Designated as safety issue: Yes ]

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.

• 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)
  Other Name: ASAQ, Coarsucam
• 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.
  Other Name: AL, Coartem(R), Riamet(R)

• Experimental: Artemether -lumefantrine
  Experimental Treatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
  Intervention: Drug: Artemether-lumefantrine
• Experimental: Artesunate-amodiaquine
  Treatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso
  Intervention: Drug: Artesunate-amodiaquine

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;