Marcel Ukah1, Olusegun Badejoko2, Solomon Ogunniyi3, Olabisi Loto3, Oladiipo Aboderin4, Adesegun Fatusi5. 1. Department of Obstetrics and Gynaecology, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria. 2. 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. 3. 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. 4. 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. 5. Department of Community Health, Obafemi Awolowo University Teaching Hospitals Complex, Ile-Ife, Nigeria; Department of Community Health, Obafemi Awolowo University, Ile-Ife, Nigeria.
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 theartesunate-amodiaquinegroup 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). CONCLUSION: Efficacies of the regimens are similar among pregnant women. However, adverse effects are more common with artesunate-amodiaquine. Pan-African Clinical Trial Registry: PACTR201310000484185.
RCT Entities:
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). CONCLUSION: Efficacies of the regimens are similar among pregnant women. However, adverse effects are more common with artesunate-amodiaquine. Pan-African Clinical Trial Registry: PACTR201310000484185.