Efficacy and safety of artemether–lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial
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. 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 o…
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AL was safe and well tolerated.
“AL was safe and well tolerated.136–138”
From Malaria in pregnancy. (2013) · cites this paper as [136]
In Uganda, artemether-Lumefantrine (AL) was efficacious, with cure rates >95%.
“In Uganda, in an area of relatively high transmission and hence with pregnant women having some acquired immunity, artemether-Lumefantrine (AL) was efficacious, with cure rates >95%.136–137”
From Malaria in pregnancy. (2013) · cites this paper as [136]
Cites
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Al Khaja, K. A. J., & Sequeira, R. P. (2021) · Malaria Journal · doi:10.1186/s12936-020-03565-2 · Cited by 39 · see citing works
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- Authors
- Piola, P., Nabasumba, C., Turyakira, E., Dhorda, M., Lindegardh, N., Nyehangane, D., Snounou, G., Ashley, E. A., McGready, R., Nosten, F., & Guerin, P. J.
- Affiliations
- University of Oxford (GB)
- Epicentre Uganda (UG)
- Mbarara University of Science and Technology (UG)
- Inserm (FR)
- Epicentre (FR)
- Mahidol University (TH)
- Corresponding author
- Piola, Patrice
- ORCID
- Venue
- The Lancet Infectious Diseases
- Publisher
- Elsevier BV
- Published
- 2010-11
- Volume
- 10
- Issue
- 11
- Pages
- 762-769
- ISSN
- 1473-3099 (ISSN-L)
- OpenAlex
- W2132453006
- Cited by
- 99
- References
- 3
- Citations by year
- 2025: 2 · 2024: 2 · 2023: 1 · 2022: 2 · 2021: 3 · 2020: 5 · 2019: 10 · 2018: 8 · 2017: 6 · 2016: 9 · 2015: 10 · 2014: 10 · 2013: 10 · 2012: 10
- FWCI
- 9.80
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet Infectious Diseases (publishedVersion)
- PubMed (publishedVersion)
- Medecins Sans Frontieres Field Research (Medecins Sans Frontieres) (submittedVersion)
- Funders
- Global Fund to Fight AIDS, Tuberculosis and Malaria
- Wellcome Trust (077166/Z/05/Z)
- University of Oxford
- Mbarara University of Science and Technology
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Phytochemical compounds biological activities
- Keywords
- artemether-lumefantrine, quinine, malaria in pregnancy, Plasmodium falciparum, uncomplicated malaria, artemisinin-based combination therapy, cure rate, drug safety, second and third trimester, malaria treatment
- MeSH terms
- Artemether, Lumefantrine Drug Combination, Adolescent, Adult, Animals, Antimalarials, Drug Combinations, Ethanolamines, Female, Fluorenes, Humans, Plasmodium falciparum, Pregnancy, Pregnancy Complications, Infectious, Quinine, Uganda, Polymerase Chain Reaction, Malaria, Falciparum, Treatment Outcome, Artemisinins, Young Adult
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