title: A randomized trial of artesunate-amodiaquine versus artemether-lumefantrine for the treatment of acute uncomplicated malaria in pregnancy.
abstract: OBJECTIVE
  To compare the artesunate-amodiaquine and artemether-lumefantrine combinations in the treatment of acute uncomplicated falciparum malaria during pregnancy.
  
  
  METHODS
  Between January and July, 2013, a double-blind randomized trial was undertaken of symptomatic pregnant women (second/third trimester) with malaria parasitemia who attended a center in Ile-Ife, Nigeria. Participants were assigned to receive artesunate-amodiaquine or artemether-lumefantrine (twice daily on days 1-3) according to a computer-generated randomization sequence. Participants and investigators were masked to group allocation. Clinical evaluations and malaria parasite counts were performed at baseline and on days 2, 3, 7, and 28. Mean interval to symptomatic relief, day-3 parasite clearance, day-28 cure rate, and adverse effects were assessed.
  
  
  RESULTS
  Of 75 women assigned to each group, 65 in the artesunate-amodiaquine group and 71 in the artemether-lumefantrine group completed the study. No significant differences between the artesunate-amodiaquine and artemether-lumefantrine groups were recorded for mean interval to symptomatic relief (2.2 ± 1.0 days vs 2.0 ± 0.8 days; P=0.090), day-3 parasite clearance (58/65 [89.2%] vs 66/71 [93.0%]; P=0.444), and day-28 cure rate (64/65 [98.5%] vs 67/71 [94.4%]; P=0.138). Adverse effects (body weakness and pruritus) were more common among women assigned to artesunate-amodiaquine (30/75 [40.0%]) than among those assigned to artemether-lumefantrine (2/75 [2.7%]; P<0.001).
  
  
  CONCLUSIONS
  Efficacies of the regimens are similar among pregnant women. However, adverse effects are more common with artesunate-amodiaquine. Pan-African Clinical Trial Registry: PACTR201310000484185.
authors.affiliation: Department of Obstetrics and Gynaecology, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria.
authors.forename: Marcel
authors.initials: M
authors.lastname: Ukah
authors.affiliation: Department of Obstetrics and Gynaecology, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria; Department of Obstetrics and Gynaecology, Obafemi Awolowo University, Ile-Ife, Nigeria. Electronic address: segunbadejoko@yahoo.co.uk.
authors.forename: Olusegun
authors.initials: O
authors.lastname: Badejoko
authors.affiliation: Department of Obstetrics and Gynaecology, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria; Department of Obstetrics and Gynaecology, Obafemi Awolowo University, Ile-Ife, Nigeria.
authors.forename: Solomon
authors.initials: S
authors.lastname: Ogunniyi
authors.affiliation: Department of Obstetrics and Gynaecology, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria; Department of Obstetrics and Gynaecology, Obafemi Awolowo University, Ile-Ife, Nigeria.
authors.forename: Olabisi
authors.initials: O
authors.lastname: Loto
authors.affiliation: Department of Microbiology and Parasitology, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria; Department of Microbiology and Parasitology, Obafemi Awolowo University, Ile-Ife, Nigeria.
authors.forename: Oladiipo
authors.initials: O
authors.lastname: Aboderin
authors.affiliation: Department of Community Health, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria; Department of Community Health, Obafemi Awolowo University, Ile-Ife, Nigeria.
authors.forename: Adesegun
authors.initials: A
authors.lastname: Fatusi
mesh_terms: D000293:Adolescent; D000328:Adult; D000655:Amodiaquine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000962:Antimalarials / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D004311:Double-Blind Method; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D005449:Fluorenes / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D016778:Malaria, Falciparum / Q000188:drug therapy*; D009549:Nigeria; D018512:Parasitemia / Q000188:drug therapy; D011247:Pregnancy; D015597:Pregnancy Complications, Parasitic / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes; C515299:amodiaquine, artesunate drug combination; D000655:Amodiaquine
keywords: Amodiaquine; Artemether; Artesunate; Lumefantrine; Malaria; Pregnancy; Resistance; Treatment