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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial
The Lancet Infectious Diseases, Volume 10, No. 11, Year 2010
Notification
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Description
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. © 2010 Elsevier Ltd.
Authors & Co-Authors
Piola, Patrice
France, Paris
Epicentre
United Kingdom, Oxford
Nuffield Department of Medicine
Nabasumba, Carolyn
France, Paris
Epicentre
Turyakira, Eleanor
France, Paris
Epicentre
Uganda, Mbarara
Mbarara University of Science and Technology
Dhorda, M. J.
France, Paris
Epicentre
Thailand, Nakhon Pathom
Mahidol University
Lindegårdh, Niklas
United Kingdom, Oxford
Nuffield Department of Medicine
Nyehangane, Dan
France, Paris
Epicentre
Snounou, Georges
France, Paris
Inserm
France, Paris
Sorbonne Université
Ashley, Elizabeth A.
France, Paris
Epicentre
United Kingdom, London
Imperial College Healthcare Nhs Trust
McGready, R. M.
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
Nuffield Department of Medicine
Thailand, Mae Sod
Shoklo Malaria Research Unit
Nosten, François Henry
Thailand, Nakhon Pathom
Mahidol University
United Kingdom, Oxford
Nuffield Department of Medicine
Thailand, Mae Sod
Shoklo Malaria Research Unit
Guérin, Philippe Jean Jean
France, Paris
Epicentre
United Kingdom, Oxford
Nuffield Department of Medicine
Statistics
Citations: 103
Authors: 11
Affiliations: 8
Identifiers
Doi:
10.1016/S1473-3099(10)70202-4
ISSN:
14733099
Research Areas
Health System And Policy
Infectious Diseases
Maternal And Child Health
Sexual And Reproductive Health
Study Design
Cohort Study
Study Locations
Uganda
Participants Gender
Female