title: Therapeutic efficacy of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Enfranze, north-west Ethiopia.
abstract: BACKGROUND
  Plasmodium falciparum accounts for approximately 60% of malaria cases in Ethiopia and artemether-lumefantrine has been used as a first-line treatment for uncomplicated P. falciparum malaria since 2004. The aim of this study was to assess the therapeutic efficacy of artemether-lumefantrine (AL) for the treatment of uncomplicated P. falciparum malaria in north-western Ethiopia.
  
  
  METHODS
  A 28-day one-arm, prospective evaluation of the clinical and parasitological response to the first-line treatment for uncomplicated P. falciparum malaria was conducted in Enfranze Health Centre in accordance with the 2009 WHO efficacy study guidelines. Patients were treated with a 3-day course of AL and clinical and parasitological parameters were monitored over a 28-day follow-up. All data from recruited patients were imported into an electronic data base and Kaplan-Meier survival analysis was used for analysing primary [early treatment failures (ETF), late clinical failure (LCF), late parasitological failures (LPF), and adequate clinical and parasitological response (ACPR)] and secondary (PCT, GCT and FCT) outcomes.
  
  
  RESULTS
  Eighty patients were enrolled and all of them completed the 28-day follow-up period. The PCR-corrected cure rate was 95.0% (95% CI 87.0-98.4%) and there were two ETF, one LCF and three LPF. Two of the LPF were classified as re infections by PCR. Seventy three point seven five percent, 91.25 and 95% of patients had cleared their parasitaemia by days 1, 2, and 3, respectively, and 75, 91.25 and 96.25% of patients had cleared their fever by days 1, 2, and 3. All patients completely cleared their gametocytes by day 7.
  
  
  CONCLUSIONS
  The relatively high cure rate, low proportion of patients still positive on day 3 as well as parasite clearance times in this study would indicate no imminent threat of artemisinin resistance development in the region. However, the threat of spreading or de novo development of artemisinin resistance warrants regular monitoring of drug efficacy throughout the region.
authors.affiliation: Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia. ggebeyaw@yahoo.com.
authors.forename: Gebeyaw
authors.initials: G
authors.lastname: Getnet
authors.affiliation: School of Medicine, College of Health Sciences and Medicine, Wolaita Sodo University, Wolaita, Ethiopia. fola.a@wehi.edu.au.|The Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia. fola.a@wehi.edu.au.
authors.forename: Abebe Alemu
authors.initials: AA
authors.lastname: Fola
authors.affiliation: Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia. agersewalemu@yahoo.com.
authors.forename: Agersew
authors.initials: A
authors.lastname: Alemu
authors.affiliation: Department of Medical Parasitology, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia. sisaygetie@yahoo.com.
authors.forename: Sisay
authors.initials: S
authors.lastname: Getie
authors.affiliation: Department of Pathobiology, Institute of Parasitology, University of Veterinary Medicine Vienna, Vienna, Austria. hans-peter.fuehrer@vetmeduni.ac.at.
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Fuehrer
authors.affiliation: Institute of Specific Prophylaxis and Tropical Medicine, Medical University of Vienna, Vienna, Austria. harald.noedl@meduniwien.ac.at.
authors.forename: Harald
authors.initials: H
authors.lastname: Noedl
mesh_terms: D000293:Adolescent; D000328:Adult; D000962:Antimalarials / Q000494:pharmacology*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000494:pharmacology*; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D004983:Ethanolamines / Q000494:pharmacology*; D005002:Ethiopia; D005260:Female; D005449:Fluorenes / Q000494:pharmacology*; D006801:Humans; D007223:Infant; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D008875:Middle Aged; D010963:Plasmodium falciparum / Q000187:drug effects*; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes