title: Open-label, randomized, non-inferiority clinical trial of artesunate-amodiaquine versus artemether-lumefantrine fixed-dose combinations in children and adults with uncomplicated falciparum malaria in Côte d'Ivoire.
abstract: BACKGROUND
  Emergence of artemisinin resistance has raised concerns that the most potent anti-malarial drug may be under threat. Artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AL) are, respectively, the first- and second-line treatments for uncomplicated falciparum malaria in Côte d'Ivoire. Constant monitoring by National Malaria Control Programme (NMCP) of drug efficacy is an important tool in establishing rational anti-malarial drug policies in Côte d'Ivoire.
  
  
  METHODS
  In an open label, randomized controlled clinical trial, children and adults were randomized to receive AS-AQ or AL. Both drug regimens were given for three days, and follow-up was for 42 days. The primary endpoint was the 42-day cure rate and was defined as proportion of patients with PCR-corrected cure rate after 42 days of follow-up.
  
  
  RESULTS
  A total of 383 patients who were attending the Anonkoua-koute (Abidjan), Petit Paris (Korhogo) and Libreville (Man) hospitals and presenting with symptomatic acute uncomplicated falciparum malaria were randomized to receive AS-AQ (188) and AL (195). The intention-to-treat analysis showed effectiveness rates of 94.7% and 96.4% for AS-AQ and AL, respectively on day 42. After adjustment for PCR, these rates were 96.8% and 99%, respectively. At day 42, in per-protocol analysis, Adequate clinical and parasitological response (ACPR) PCR uncorrected was 97.8% and 97.4% for AS-AQ and AL, respectively. The PCR adjusted ACPR was 100% for each combination and both regimens were well tolerated.
  
  
  CONCLUSIONS
  This study has shown the high efficacy of AS-AQ in patients of all ages with acute uncomplicated falciparum malaria and AS-AQ was non-inferior to AL. Continuous efficacy monitoring is recommended.
authors.affiliation: Malariology Unit, Institut Pasteur de Côte d'Ivoire, PO Box 490, Abidjan 01, Côte d'Ivoire. andre_offianan@yahoo.fr.
authors.forename: Offianan A
authors.initials: OA
authors.lastname: Toure
authors.forename: Serge B
authors.initials: SB
authors.lastname: Assi
authors.forename: Tiacoh L
authors.initials: TL
authors.lastname: N'Guessan
authors.forename: Gbessi E
authors.initials: GE
authors.lastname: Adji
authors.forename: Aristide B
authors.initials: AB
authors.lastname: Ako
authors.forename: Marie J
authors.initials: MJ
authors.lastname: Brou
authors.forename: Marie F
authors.initials: MF
authors.lastname: Ehouman
authors.forename: Laeticia A
authors.initials: LA
authors.lastname: Gnamien
authors.forename: M'Lanhoro A A
authors.initials: MA
authors.lastname: Coulibaly
authors.forename: Baba
authors.initials: B
authors.lastname: Coulibaly
authors.forename: Sylvain
authors.initials: S
authors.lastname: Beourou
authors.forename: Issiaka
authors.initials: I
authors.lastname: Bassinka
authors.forename: Adama
authors.initials: A
authors.lastname: Soumahoro
authors.forename: Florence
authors.initials: F
authors.lastname: Kadjo
authors.forename: Mea A
authors.initials: MA
authors.lastname: Tano
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000655:Amodiaquine / Q000008:administration & dosage*; D000962:Antimalarials / Q000008:administration & dosage*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000008:administration & dosage*; 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*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; 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