title: Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria at sentinel sites in Mozambique, 2015.
abstract: The resistance of Plasmodium falciparum to anti-malarial drugs continues to challenge malaria control. We assessed the therapeutic efficacy and safety of artemether-lumefantrine (AL), the first-line treatment of uncomplicated P. falciparum malaria, in children under five years of age in Mozambique. We conducted a prospective one-arm study to evaluate the clinical and parasitological efficacy of AL over 28days at four sentinel sites, using the WHO protocol for assessing the efficacy of antimalarial treatment. msp1, msp2 and glurp genes were analysed by DNA polymerase chain reaction (PCR) to differentiate recrudescence from re-infection with malaria parasites. Haemoglobin concentration was recorded at baseline and on days 7, 14 and 28. A total of 349 children with uncomplicated falciparum malaria were recruited at the four sentinel sites. Adequate clinical and parasitological response to AL on day 28 follow-up varied from 96.3% to 100% after correction by PCR. The drug was well tolerated, and no adverse event related to the drug was reported. AL, the current first-line treatment for uncomplicated falciparum malaria in Mozambique, remains highly efficacious at the study sites. Monitoring of the efficacy of the recommended antimalarial drugs should be continued in order to detect any emerging threat to their efficacy.
  
  
  BACKGROUND
  ACTRN12616001680459.
authors.affiliation: Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique.
authors.forename: Crizolgo
authors.initials: C
authors.lastname: Salvador
authors.affiliation: Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique.
authors.forename: Bernardete
authors.initials: B
authors.lastname: Rafael
authors.affiliation: Programa Nacional de Controlo da Malária, Ministério da Saúde, Maputo, Mozambique.
authors.forename: Francisco
authors.initials: F
authors.lastname: Matsinhe
authors.affiliation: Programa Nacional de Controlo da Malária, Ministério da Saúde, Maputo, Mozambique.
authors.forename: Baltazar
authors.initials: B
authors.lastname: Candrinho
authors.affiliation: Programa Nacional de Controlo da Malária, Ministério da Saúde, Maputo, Mozambique.
authors.forename: Rosália
authors.initials: R
authors.lastname: Muthemba
authors.affiliation: World Health Organization, WHO Country Office Maputo, Mozambique.
authors.forename: Eva
authors.initials: E
authors.lastname: De Carvalho
authors.affiliation: Fundação Ariel Glaser, Maputo, Mozambique.
authors.forename: Eva
authors.initials: E
authors.lastname: Naueia
authors.affiliation: Faculdade de Medicina,Universidade Eduardo Mondlane, Maputo, Mozambique.
authors.forename: Jahit
authors.initials: J
authors.lastname: Sacarlal
authors.affiliation: World Health Organization, WHO Country Office Asmara, Eritrea.
authors.forename: Josephine
authors.initials: J
authors.lastname: Namboze
authors.affiliation: Faculdade de Medicina,Universidade Eduardo Mondlane, Maputo, Mozambique.
authors.forename: Armindo
authors.initials: A
authors.lastname: Tiago
authors.affiliation: World Health Organization, Global Malaria Programme, Geneva, Switzerland. Electronic address: warsamem@who.int.
authors.forename: Marian
authors.initials: M
authors.lastname: Warsame
authors.affiliation: Instituto Nacional de Saúde, Ministério da Saúde, Maputo, Mozambique.
authors.forename: Sónia
authors.initials: S
authors.lastname: Enosse
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* / Q000453:epidemiology / Q000469:parasitology; D008297:Male; D009073:Mozambique; D010963:Plasmodium falciparum / Q000235:genetics; D016133:Polymerase Chain Reaction; D011446:Prospective Studies; D012008:Recurrence
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes
keywords: Artemeter–lumefantrine; Efficacy and safety; Mozambique; Plasmodium falciparum