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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Piola, PatriceNabasumba, Carolyn
Turyakira, Eleanor
Dhorda, Mehul
Lindegardh, Niklas
Nyehangane, Dan
Snounou, Georges
Ashley, Elizabeth A
McGready, Rose
Nosten, Francois
Guerin, Philippe J
Affiliation
Epicentre, 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, ThailandIssue Date
2010-10-05
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The Lancet Infectious DiseasesAbstract
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.PubMed ID
20932805Additional Links
http://www.thelancet.com/journals/laninf/article/PIIS1473-3099%2810%2970202-4/abstractType
ArticleLanguage
enISSN
1474-4457ae974a485f413a2113503eed53cd6c53
10.1016/S1473-3099(10)70202-4