title: Effectiveness of quinine versus artemether-lumefantrine for treating uncomplicated falciparum malaria in Ugandan children: randomised trial.
abstract: OBJECTIVE
  To compare the effectiveness of oral quinine with that of artemether-lumefantrine in treating uncomplicated malaria in children.
  
  
  METHODS
  Randomised, open label effectiveness study.
  
  
  METHODS
  Outpatient clinic of Uganda's national referral hospital in Kampala.
  
  
  METHODS
  175 children aged 6 to 59 months with uncomplicated malaria.
  
  
  METHODS
  Participants were randomised to receive oral quinine or artemether-lumefantrine administered by care givers at home.
  
  
  METHODS
  Primary outcomes were parasitological cure rates after 28 days of follow-up unadjusted and adjusted by genotyping to distinguish recrudescence from new infections. Secondary outcomes were adherence to study drug, presence of gametocytes, recovery of haemoglobin concentration from baseline at day 28, and safety profiles.
  
  
  RESULTS
  Using survival analysis the cure rate unadjusted by genotyping was 96% for the artemether-lumefantrine group compared with 64% for the quinine group (hazard ratio 10.7, 95% confidence interval 3.3 to 35.5, P=0.001). In the quinine group 69% (18/26) of parasitological failures were due to recrudescence compared with none in the artemether-lumefantrine group. The mean adherence to artemether-lumefantrine was 94.5% compared with 85.4% to quinine (P=0.0008). Having adherence levels of 80% or more was associated with a decreased risk of treatment failure (0.44, 0.19 to 1.02, P=0.06). Adverse events did not differ between the two groups.
  
  
  CONCLUSIONS
  The effectiveness of a seven day course of quinine for the treatment of uncomplicated malaria in Ugandan children was significantly lower than that of artemether-lumefantrine. These findings question the advisability of the recommendation for quinine therapy for uncomplicated malaria in Africa.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00540202.
authors.affiliation: Makerere University School of Health Sciences, PO Box 7475, Kampala, Uganda. achanj@yahoo.co.uk
authors.forename: Jane
authors.initials: J
authors.lastname: Achan
authors.forename: James K
authors.initials: JK
authors.lastname: Tibenderana
authors.forename: Daniel
authors.initials: D
authors.lastname: Kyabayinze
authors.forename: Fred
authors.initials: F
authors.lastname: Wabwire Mangen
authors.forename: Moses R
authors.initials: MR
authors.lastname: Kamya
authors.forename: Grant
authors.initials: G
authors.lastname: Dorsey
authors.forename: Umberto
authors.initials: U
authors.lastname: D'Alessandro
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Rosenthal
authors.forename: Ambrose O
authors.initials: AO
authors.lastname: Talisuna
mesh_terms: D000962:Antimalarials / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D016778:Malaria, Falciparum / Q000188:drug therapy*; D008297:Male; D055118:Medication Adherence; D011803:Quinine / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; D011803:Quinine