In Vivo and in Vitro Efficacy of Antimalarial Treatments in Children in Burkina Faso
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      Resistance to antimalarial drugs represents a major obstacle for controlling malaria in
      endemic countries, so that most sub-Saharan countries have changed their antimalarial drug
      policy to the new Artemisinin Containing Therapies. Burkina Faso has changed its policy for
      uncomplicated malaria to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS), but
      there are still little available data on safety and efficacy of these treatments in Burkina
      Faso; both treatments have shown to be efficacious, but AL seems to have higher occurrence of
      recurrent malaria infections during a 28-day follow up period. Thus, this study aims at
      comparing the safety and efficacy of AL and AS-AQ (42-day follow-up), AND also at comparing
      their in vitro sensitivity, in patients with recurrent infection, with the results obtained
      in vivo.
    

Detailed description: 
      Plasmodium falciparum resistance to antimalarial drugs represents the major drawback and
      obstacle for controlling malaria in endemic countries; that's why most sub-Saharan countries
      have changed their antimalarial drug policy to Artemisinin Containing Therapies (ACT), which
      produce a rapid clinical and parasitological cure, reduce gametocyte carriage rate and are
      generally well tolerated. Burkina Faso has recently changed its policy for the treatment of
      uncomplicated malaria, from Chloroquine to Artemether-Lumefantrine (AL) and
      Artesunate-Amodiaquine (AQ+AS). However, there are still little available data on safety and
      efficacy of these treatments in Burkina Faso; a recent study carried out in Bobo Dioulasso
      showed that both treatments were extremely efficacious (adjusted treatment failure less than
      5%) but with AL showing significantly high occurrence of recurrent infections during the
      28-day follow up period. The higher risk for recurrent infections for AL was confirmed in a
      subsequent trial comparing AL with AQ-SP and dihydroartemisinin-piperaquine, but so far no
      direct comparison between AQ+AS and AL has been completed, though a study in Nanoro, near
      Ouagadougou, is ongoing. Thus, the present study aims at comparing the in vivo safety and
      efficacy of AL and AS-AQ (42-day follow-up),AND at comparing the in vitro sensitivity of the
      different ACT components, in patients with recurrent infection, with the results obtained in
      vivo.
    

Intervention name(s): Artesunate-amodiaquine; Artemether-lumefantrine
Intervention type(s): Drug; Drug
Intervention description(s): 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); 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 intervention name(s): ASAQ, Coarsucam; AL, Coartem(R), Riamet(R)
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Artemether, Lumefantrine Drug Combination; Amodiaquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uncomplicated malaria; P falciparum; Children; National treatment protocol; Burkina Faso; Artemether-lumefantrine; Artesunate-amodiaquine; In vivo efficacy; In vitro efficacy