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dc.contributor.authorPiola, Patrice
dc.contributor.authorNabasumba, Carolyn
dc.contributor.authorTuryakira, Eleanor
dc.contributor.authorDhorda, Mehul
dc.contributor.authorLindegardh, Niklas
dc.contributor.authorNyehangane, Dan
dc.contributor.authorSnounou, Georges
dc.contributor.authorAshley, Elizabeth A
dc.contributor.authorMcGready, Rose
dc.contributor.authorNosten, Francois
dc.contributor.authorGuerin, Philippe J
dc.date.accessioned2010-11-25T19:37:19Z
dc.date.available2010-11-25T19:37:19Z
dc.date.issued2010-10-05
dc.identifier.citationLancet Infect Dis 2010;10(11):762-9en
dc.identifier.issn1474-4457
dc.identifier.pmid20932805
dc.identifier.doi10.1016/S1473-3099(10)70202-4
dc.identifier.urihttp://hdl.handle.net/10144/116337
dc.description.abstractBACKGROUND: 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.
dc.languageENG
dc.language.isoenen
dc.relation.urlhttp://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2810%2970202-4/abstracten
dc.rightsPublished by Elsevier Reproduced on this site with permission of Elsevier Ltd. Please see [url]http://www.thelancet.com/journals/laninf[/url] for further relevant comment.en
dc.subject.meshMalariaen
dc.subject.meshPregnant Womenen
dc.subject.meshPregnancyen
dc.subject.meshTreatmenten
dc.subject.meshCoartemen
dc.subject.meshartemether-lumefantrine combinationen
dc.subject.meshArtemisininsen
dc.subject.meshQuinineen
dc.subject.meshAntimalarialsen
dc.subject.meshUgandaen
dc.subject.meshSub-Saharan Africaen
dc.titleEfficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trialen
dc.typeArticleen
dc.contributor.departmentEpicentre, Paris, France; Epicentre, Mbarara, Uganda; Mbarara University of Science & Technology, Mbarara, Uganda; Mahidol-Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Clinical Vaccinology and Tropical Medicine, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK; INSERM UMR S945, Paris, France; Université Pierre & Marie Curie, Faculté de Médecine Pitié-Salpêtrière, Paris, France; Department of Microbiology, Imperial College NHS Trust, London, UK; Shoklo Malaria Research Unit, Mae Sot, Tak, Thailanden
dc.identifier.journalThe Lancet Infectious Diseasesen
refterms.dateFOA2019-03-04T08:30:33Z
html.description.abstractBACKGROUND: 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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