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Efficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial.
- Source :
-
The Lancet. Infectious diseases [Lancet Infect Dis] 2010 Nov; Vol. 10 (11), pp. 762-9. - Publication Year :
- 2010
-
Abstract
- Background: Malaria in pregnancy is associated with maternal and fetal morbidity and mortality. In 2006, WHO recommended use of artemisinin-based combination treatments during the second or third trimesters, but data on efficacy and safety in Africa were scarce. We aimed to assess whether artemether-lumefantrine was at least as efficacious as oral quinine for the treatment of uncomplicated falciparum malaria during the second and third trimesters of pregnancy in Mbarara, Uganda.<br />Methods: We did an open-label, randomised, non-inferiority trial between October, 2006, and May, 2009, at the antenatal clinics of the Mbarara University of Science and Technology Hospital in Uganda. Pregnant women were randomly assigned (1:1) by computer generated sequence to receive either quinine hydrochloride or artemether-lumefantrine, and were followed up weekly until delivery. Our primary endpoint was cure rate at day 42, confirmed by PCR. The non-inferiority margin was a difference in cure rate of 5%. Analysis of efficacy was for all randomised patients without study deviations that could have affected the efficacy outcome. This study was registered with ClinicalTrials.gov, number NCT00495508.<br />Findings: 304 women were randomly assigned, 152 to each treatment group. By day 42, 16 patients were lost to follow-up and 25 were excluded from the analysis. At day 42, 137 (99.3%) of 138 patients taking artemether-lumefantrine and 122 (97.6%) of 125 taking quinine were cured-difference 1.7% (lower limit of 95% CI -0.9). There were 290 adverse events in the quinine group and 141 in the artemether-lumefantrine group.<br />Interpretation: Artemisinin derivatives are not inferior to oral quinine for the treatment of uncomplicated malaria in pregnancy and might be preferable on the basis of safety and efficacy.<br />Funding: Médecins Sans Frontières and the European Commission.<br /> (Copyright © 2010 Elsevier Ltd. All rights reserved.)
- Subjects :
- Adolescent
Adult
Animals
Artemether, Lumefantrine Drug Combination
Artemisinins adverse effects
Drug Combinations
Ethanolamines adverse effects
Female
Fluorenes adverse effects
Humans
Plasmodium falciparum drug effects
Plasmodium falciparum isolation & purification
Polymerase Chain Reaction
Pregnancy
Quinine adverse effects
Treatment Outcome
Uganda
Young Adult
Antimalarials administration & dosage
Artemisinins administration & dosage
Ethanolamines administration & dosage
Fluorenes administration & dosage
Malaria, Falciparum drug therapy
Pregnancy Complications, Infectious drug therapy
Quinine administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1474-4457
- Volume :
- 10
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- The Lancet. Infectious diseases
- Publication Type :
- Academic Journal
- Accession number :
- 20932805
- Full Text :
- https://doi.org/10.1016/S1473-3099(10)70202-4