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Efficacy, safety, and tolerability of amodiaquine plus sulphadoxine-pyrimethamine used alone or in combination for malaria treatment in pregnancy: a randomised trial
Abstract
Background The widespread increase in resistance of Plasmodium falciparum to chloroquine and sulphadoxine-pyrimethamine threatens the use of these drugs for malaria treatment in pregnancy. We aimed to assess the safety and efficacy of amodiaquine alone or in combination with sulphadoxine-pyrimethamine as alternative regimens. Methods Pregnant women with a gestational age of 16 weeks or more who attended antenatal clinics at a district hospital in Ghana were screened for malaria with OptiMAL dipsticks. 900 pregnant women who had a positive test result and P falciparum asexual stage parasitaemia were enrolled and randomly assigned chloroquine, sulphadoxine-pyrimethamine, amodiaquine, or amodiaquine plus sulphadoxine-pyrimethamine. The primary outcome was parasitological failure by day 28 of treatment. Women were seen on days 3, 7, 14, and 28 after the start of treatment to assess the effect of treatment on peripheral parasitaemia, haemoglobin concentration, white-blood-cell count, and liver function. Additionally, reports of adverse effects were solicited and monitored during follow-up visits. Analysis was by intention to treat. This trial is registered with the US National Institute of Health clinical trials database number NCT00131703. Findings PCR-corrected parasitological failure by day 28 was 14%, 11%, 3%, and 0% in the women assigned chloroquine, sulphadoxine-pyrimethamine, amodiaquine, and amodiaquine plus sulphadoxine-pyrimethamine, respectively (p Interpretation Amodia…
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Amodiaquine has been shown to be efficacious in pregnant women with falciparum malaria in Ghana and Tanzania.
“Amodiaquine (AQ) has been shown to be efficacious in pregnant women with falciparum malaria in Ghana and Tanzania.122,125”
From Malaria in pregnancy. (2013) · cites this paper as [122]
Data available indicate that ACTs are relatively safe for the foetus when taken after the first trimester of pregnancy.
“Data available indicate that ACTs are relatively safe for the foetus when taken after the first trimester of pregnancy.”
From Malaria in pregnancy. (2013) · cites this paper as [122]
Day 28 parasitological failure rates were 3% for AQ monotherapy, 0-1% for the combination AQ+SP, and 4.5% for the combination AS+AQ.
“Day 28 parasitological failure rates were 3% for AQ monotherapy,122 0–1% for the combination AQ+SP,122,125 and 4.5% for the combination AS+AQ.125”
From Malaria in pregnancy. (2013) · cites this paper as [122]
Citations
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Reducing the burden of malaria in pregnancy by preventive strategies
Menéndez, C., D'Alessandro, U., & ter Kuile, F. O. (2007) · The Lancet Infectious Diseases · doi:10.1016/s1473-3099(07)70024-5 · Cited by 188
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Self-citationIntermittent preventive treatment regimens for malaria in HIV-positive pregnant women
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Metadata
- Authors
- Tagbor, H., Bruce, J., Browne, E., Randal, A., Greenwood, B., & Chandramohan, D.
- Affiliations
- London School of Hygiene & Tropical Medicine (GB)
- Kwame Nkrumah University of Science and Technology (GH)
- Corresponding author
- Tagbor, Harry
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2006-10
- Volume
- 368
- Issue
- 9544
- Pages
- 1349-1356
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2032224522
- Cited by
- 81
- References
- 2
- Citations by year
- 2025: 1 · 2022: 3 · 2021: 1 · 2020: 1 · 2019: 2 · 2018: 3 · 2017: 3 · 2016: 2 · 2015: 4 · 2014: 4 · 2013: 7 · 2012: 3
- FWCI
- 11.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Lancet (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Foundation for the National Institutes of Health
- Bill and Melinda Gates Foundation
- National Institute for Health and Care Research
- National Institutes of Health
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Drug Discovery › Phytochemical compounds biological activities
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
- Keywords
- malaria in pregnancy, amodiaquine, sulfadoxine-pyrimethamine, Plasmodium falciparum, chloroquine resistance, antimalarial drug efficacy, adverse drug reactions, combination antimalarial therapy
- MeSH terms
- Adult, Amodiaquine, Antimalarials, Chloroquine, Drug Administration Schedule, Drug Combinations, Female, Ghana, Humans, Pregnancy, Pyrimethamine, Sulfadoxine, Pregnancy Complications, Parasitic, Malaria, Falciparum
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