title: Assessment of the therapeutic efficacy of a paediatric formulation of artemether-lumefantrine (Coartesiane) for the treatment of uncomplicated Plasmodium falciparum in children in Zambia.
abstract: BACKGROUND
  Sentinel site surveillance of antimalarials by in-vivo therapeutic efficacy studies in Zambia is one of the key activities ear-marked for monitoring and evaluation. The studies are conducted annually in order to provide timely and reliable information on the status of the recommended regimens for malaria case management. The findings of the therapeutic efficacy of an artemisinin-based combination therapy of pediatric artemether-lumefantrine (Coartesiane) are reported.
  
  
  METHODS
  The design is a simple, one-arm, prospective evaluation of the clinical and parasitological response to directly observed treatment for uncomplicated malaria. The study was conducted in sentinel sites using the WHO standardized protocol for the assessment of therapeutic efficacy of antimalarial drugs (WHO 2000) in children under five years of age, weighing less than 10 Kg. The study was conducted at two clinics, one in Chongwe (Lusaka Province) and Chipata (Eastern Province). The 28-day follow-up period was used coupled with PCR genotyping for MSP1 and MSP2 in order to differentiate recrudescence from re-infections for parasites that appeared after Day 14.
  
  
  RESULTS
  91/111 children enrolled in the study, were successfully followed up. Artemether-lumefantrine (Coartesiane) was found to produce significant gametocyte reduction. The Adequate Clinical and Parasitological Response (ACPR) was found to be 100% (95% CI 96.0;100).
  
  
  CONCLUSIONS
  Coartesiane was effective in treating uncomplicated malaria in Zambian children weighing less than 10 kg, an age group normally excluded from taking the tablet formulation of artemether-lumefantrine (Coartem).
authors.affiliation: National Malaria Control Centre, P.O. Box 32509, Lusaka, Zambia. pascychanda@mailcity.com
authors.forename: Pascalina
authors.initials: P
authors.lastname: Chanda
authors.forename: Moonga
authors.initials: M
authors.lastname: Hawela
authors.forename: Mabvuto
authors.initials: M
authors.lastname: Kango
authors.forename: Naawa
authors.initials: N
authors.lastname: Sipilanyambe
mesh_terms: D000818:Animals; D000962:Antimalarials / Q000008:administration & dosage / Q000627:therapeutic use; D000077549:Artemether; D037621:Artemisinins / Q000008:administration & dosage* / Q000627:therapeutic use*; D002675:Child, Preschool; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage* / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage* / Q000627:therapeutic use*; D006801:Humans; D000078102:Lumefantrine; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000469:parasitology; D008297:Male; D010963:Plasmodium falciparum; D015024:Zambia
chemical_list: D000962:Antimalarials; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; D000077549:Artemether; D000078102:Lumefantrine