title: Multicentre study evaluating the non-inferiority of the new paediatric formulation of artesunate/amodiaquine versus artemether/lumefantrine for the management of uncomplicated Plasmodium falciparum malaria in children in Cameroon, Ivory Coast and Senegal.
abstract: BACKGROUND
  This multicentre study was carried out in Cameroon, Ivory Coast and Senegal to evaluate the non-inferiority of the new paediatric formulation of artesunate/amodiaquine (AS+AQ)(Camoquin-Plus Paediatric®) in suspension form versus artemether/lumefantrine (AL)(Coartem®) in the management of African children with uncomplicated falciparum malaria.
  
  
  METHODS
  It was an open randomized trial including children aged between 7 months and 7 years. The endpoints were Adequate Clinical and Parasitological Response (ACPR) at day 28, the clinical and biological tolerability. Statistical analyses were done in Intention To Treat (ITT) and in Per protocol (PP).
  
  
  RESULTS
  At the end of the study 481 patients were enrolled in the three countries (249 in the AS+AQ arm and 232 in the AL arm). ACRP in ITT after PCR correction did not show any statistical difference between the two groups with 97.6% for AS+AQ versus 94.8% for AL. In the PP analysis, the corrected ACRP were respectively 98.7% and 96.9% for the two regimens. The clinical tolerance was good without significant difference. Anaemia was significantly higher at D7 in the two groups compared to D0.
  
  
  CONCLUSIONS
  This study demonstrates the non-inferiority of AS+AQ versus AL, its efficacy and tolerance in the management of uncomplicated Plasmodium falciparum malaria in African children.
authors.affiliation: Service de Parasitologie-Mycologie, Faculté de Médecine, Université Cheikh Anta Diop, Dakar Fann, Dakar, BP 5005, Sénégal. bfaye67@yahoo.fr
authors.forename: Babacar
authors.initials: B
authors.lastname: Faye
authors.forename: Thomas
authors.initials: T
authors.lastname: Kuété
authors.forename: Christiane P
authors.initials: CP
authors.lastname: Kiki-Barro
authors.forename: Roger C
authors.initials: RC
authors.lastname: Tine
authors.forename: Thérèse
authors.initials: T
authors.lastname: Nkoa
authors.forename: Jean Louis A
authors.initials: JL
authors.lastname: Ndiaye
authors.forename: Claude A
authors.initials: CA
authors.lastname: Kakpo
authors.forename: Khadime
authors.initials: K
authors.lastname: Sylla
authors.forename: Hervé
authors.initials: H
authors.lastname: El Menan
authors.forename: Oumar
authors.initials: O
authors.lastname: Gaye
authors.forename: Oumar
authors.initials: O
authors.lastname: Faye
authors.forename: Albert
authors.initials: A
authors.lastname: Same-Ekobo
authors.forename: Koné
authors.initials: K
authors.lastname: Moussa
mesh_terms: D000655:Amodiaquine / Q000008:administration & dosage*; D000962:Antimalarials / Q000008:administration & dosage*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000008:administration & dosage*; D002163:Cameroon; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D007560:Cote d'Ivoire; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage*; D006801:Humans; D007223:Infant; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D059208:Parasite Load; D012675:Senegal; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; C515299:amodiaquine, artesunate drug combination; D000655:Amodiaquine