title: Efficacy and tolerability of artesunate-amodiaquine (Camoquin plus) versus artemether-lumefantrine (Coartem) against uncomplicated Plasmodium falciparum malaria: multisite trial in Senegal and Ivory Coast.
abstract: OBJECTIVE
  To compare, in a phase IV trial, the efficacy and tolerability of artesunate-amodiaquine (Camoquin plus) dosed at 300 and 600 mg of amodiaquine per tablet to artemether-lumefantrine (Coartem) for the treatment of Plasmodium falciparum uncomplicated malaria in Ivory Coast and Senegal.
  
  
  METHODS
  Multisite, randomised, open-labelled study in patients over the age of 7 years. The primary endpoint for efficacy was adequate clinical and parasitological response (ACPR) at day 28. The secondary endpoints were fever and parasite clearance and gametocyte carriage in each treatment group. Drug tolerability was assessed comparing adverse events and modification of biological parameters between D0 and D7. Data were analysed on an intention-to-treat and per protocol basis.
  
  
  RESULTS
  We included 322 patients; 316 patients completed the monitoring to D28 (155 in AS + AQ group and 161 in AL group). In ITT analysis, an ACPR corrected rate of 97.4% was observed in AS + AQ group versus 97% in AL group (P = 0.99). No parasite recrudescence was observed in AS + AQ arm. All patients in both groups had a fever and parasite clearance at D2. Gametocytes had disappeared by D14 in the AL group and by D21 in the AS + AQ group. No serious adverse events were observed. Minor adverse events were significantly more frequent in the AS + AQ arm. Biological parameters between D0 and D7 did not show any significant statistical variations except for anaemia.
  
  
  CONCLUSIONS
  This study demonstrates the efficacy and tolerability of AS + AQ for uncomplicated Plasmodium falciparum malaria treatment in African patients over the age of 7 years.
authors.affiliation: Service de Parasitologie-Mycologie Médicale, Université Cheikh Anta Diop, Dakar Fann, Senegal. bfaye67@yahoo.fr
authors.forename: Babacar
authors.initials: B
authors.lastname: Faye
authors.forename: André Touré
authors.initials: AT
authors.lastname: Offianan
authors.forename: Jean Louis
authors.initials: JL
authors.lastname: Ndiaye
authors.forename: Roger Clement
authors.initials: RC
authors.lastname: Tine
authors.forename: Walatchin
authors.initials: W
authors.lastname: Touré
authors.forename: Kali
authors.initials: K
authors.lastname: Djoman
authors.forename: Khadime
authors.initials: K
authors.lastname: Sylla
authors.forename: Paulette Suzanne
authors.initials: PS
authors.lastname: Ndiaye
authors.forename: Louis
authors.initials: L
authors.lastname: Penali
authors.forename: Oumar
authors.initials: O
authors.lastname: Gaye
mesh_terms: D000293:Adolescent; D000328:Adult; D000655:Amodiaquine / Q000009:adverse effects / Q000627:therapeutic use*; D000962:Antimalarials / Q000009:adverse effects / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D007560:Cote d'Ivoire; D004338:Drug Combinations; D004983:Ethanolamines / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D010963:Plasmodium falciparum / Q000187:drug effects; D012675:Senegal; D013223:Statistics as Topic; D055815:Young Adult
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