| Efficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial. | |
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MedLine Citation:
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PMID: 20932805 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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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. 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. 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. 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. FUNDING: Médecins Sans Frontières and the European Commission. |
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Authors:
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Patrice Piola; Carolyn Nabasumba; Eleanor Turyakira; Mehul Dhorda; Niklas Lindegardh; Dan Nyehangane; Georges Snounou; Elizabeth A Ashley; Rose McGready; Francois Nosten; Philippe J Guerin |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The Lancet infectious diseases Volume: 10 ISSN: 1474-4457 ISO Abbreviation: Lancet Infect Dis Publication Date: 2010 Nov |
Date Detail:
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Created Date: 2010-10-29 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101130150 Medline TA: Lancet Infect Dis Country: United States |
Other Details:
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Languages: eng Pagination: 762-9 Citation Subset: IM |
Copyright Information:
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Copyright © 2010 Elsevier Ltd. All rights reserved. |
Affiliation:
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Epicentre, Paris, France. patrice.piola@wwarn.org |
Export Citation:
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Descriptor/Qualifier:
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| Grant Support | |
ID/Acronym/Agency:
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077166/Z/05/Z//Wellcome Trust |
| Comments/Corrections | |
Comment In:
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Lancet Infect Dis. 2010 Nov;10(11):739-40
[PMID:
21029982
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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