title: Artemether-lumefantrine versus artemisinin-naphthoquine in Papua New Guinean children with uncomplicated malaria: a six months post-treatment follow-up study.
abstract: BACKGROUND
  In a recent trial of artemisinin-naphthoquine (artemisinin-NQ) and artemether-lumefantrine (AM-LM) therapy in young children from Papua New Guinea (PNG), there were no treatment failures in artemisinin-NQ-treated children with Plasmodium falciparum or Plasmodium vivax compared with 2.2% and 30.0%, respectively, in AM-LM-treated children during 42 days of follow-up. To determine whether, consistent with the long elimination half-life of NQ, this difference in efficacy would be more durable, clinical episodes of malaria were assessed in a subset of trial patients followed for six months post-treatment.
  
  
  METHODS
  For children completing trial procedures and who were assessable at six months, all within-trial and subsequent clinical malaria episodes were ascertained, the latter by clinic attendances and/or review of hand-held health records. Presentations with non-malarial illness were also recorded. Differences between allocated treatments for pre-specified endpoints were determined using Kaplan-Meier survival analysis.
  
  
  RESULTS
  Of 247 children who were followed to Day 42, 176 (71.3%) were included in the present sub-study, 87 allocated to AM-LM and 89 to artemisinin-NQ. Twenty children in the AM-LM group (32.8%) had a first episode of clinical malaria within six months compared with 10 (16.4%) in the artemisinin-NQ group (P = 0.033, log rank test). The median (interquartile range) time to first episode of clinical malaria was 64 (50-146) vs 116 (77-130) days, respectively (P = 0.20). There were no between-group differences in the incidence of first presentation with non-malarial illness (P = 0.31).
  
  
  CONCLUSIONS
  The greater effectiveness of artemisinin-NQ over conventional AM-LM extends to at least six months post-treatment for clinical malaria but not non-malarial illness.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ACTRN12610000913077 .
authors.affiliation: School of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, PO Box 480, Fremantle, 6959, WA, Australia. drmlaman@yahoo.com.|Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea. drmlaman@yahoo.com.
authors.forename: Moses
authors.initials: M
authors.lastname: Laman
authors.affiliation: Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea. jmbenjamin1606@gmail.com.
authors.forename: John M
authors.initials: JM
authors.lastname: Benjamin
authors.affiliation: School of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, PO Box 480, Fremantle, 6959, WA, Australia. brioni.moore@uwa.edu.au.|Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea. brioni.moore@uwa.edu.au.
authors.forename: Brioni R
authors.initials: BR
authors.lastname: Moore
authors.affiliation: Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea. Mary.Salib@pngimr.org.pg.
authors.forename: Mary
authors.initials: M
authors.lastname: Salib
authors.affiliation: Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea. Somoyang.Tawat@pngimr.org.pg.
authors.forename: Somoyang
authors.initials: S
authors.lastname: Tawat
authors.affiliation: School of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, PO Box 480, Fremantle, 6959, WA, Australia. wendy.davis@uwa.edu.au.
authors.forename: Wendy A
authors.initials: WA
authors.lastname: Davis
authors.affiliation: Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea. Peter.Siba@pngimr.org.pg.
authors.forename: Peter M
authors.initials: PM
authors.lastname: Siba
authors.affiliation: Papua New Guinea Institute of Medical Research, Madang, Papua New Guinea. robinson@wehi.edu.au.|Infection and Immunity Division, Walter and Eliza Hall Institute, Parkville, VIC, Australia. robinson@wehi.edu.au.|Department of Medical Biology, University of Melbourne, Melbourne, VIC, Australia. robinson@wehi.edu.au.
authors.forename: Leanne J
authors.initials: LJ
authors.lastname: Robinson
authors.affiliation: School of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, PO Box 480, Fremantle, 6959, WA, Australia. tim.davis@uwa.edu.au.
authors.forename: Timothy M E
authors.initials: TM
authors.lastname: Davis
mesh_terms: D000962:Antimalarials / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000627:therapeutic use*; D002675:Child, Preschool; D004338:Drug Combinations; D004983:Ethanolamines / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006207:Half-Life; D006801:Humans; D007223:Infant; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000453:epidemiology; D016780:Malaria, Vivax / Q000188:drug therapy* / Q000453:epidemiology; D008297:Male; D009285:Naphthoquinones / Q000627:therapeutic use*; D010219:Papua New Guinea / Q000453:epidemiology; D010963:Plasmodium falciparum; D010966:Plasmodium vivax; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; D009285:Naphthoquinones; C543979:artemisinin-naphthoquine combination