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Cited by 75Malaria Research and ControlPhytochemical compounds biological activitiesPharmaceutical Quality and Counterfeiting

A Randomized Controlled Pilot Trial of Azithromycin or Artesunate Added to Sulfadoxine-Pyrimethamine as Treatment for Malaria in Pregnant Women

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Kalilani, Linda, Mofolo, Innocent, Chaponda, Marjorie, Rogerson, Stephen J., Alker, Alisa P., Kwiek, Jesse J., Meshnick, Steven R.·2007·PLoS ONE
DOI 10.1371/journal.pone.0001166PMC PMC2048661
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Abstract

OBJECTIVE: New anti-malarial regimens are urgently needed in sub-Saharan Africa because of the increase in drug resistance. We investigated the safety and efficacy of azithromycin or artesunate combined with sulfadoxine-pyrimethamine used for treatment of malaria in pregnant women in Blantyre, Malawi. METHODS/FINDINGS: This was a randomized open-label clinical trial, conducted at two rural health centers in Blantyre district, Malawi. A total of 141 pregnant women with uncomplicated Plasmodium falciparum malaria were recruited and randomly allocated to 3 treatment groups: sulfadoxine-pyrimethamine (SP; 3 tablets, 500 mg sulfadoxine and 25 mg pyrimethamine per tablet); SP plus azithromycin (1 g/dayx2 days); or SP plus artesunate (200 mg/dayx3 days). Women received two doses administered at least 4 weeks apart. Heteroduplex tracking assays were performed to distinguish recrudescence from new infections. Main outcome measures were incidence of adverse outcomes, parasite and fever clearance times and recrudescence rates. All treatment regimens were well tolerated. Two women vomited soon after ingesting azithromycin. The parasite clearance time was significantly faster in the SP-artesunate group. Recrudescent episodes of malaria were less frequent with SP-azithromycin [Hazard Ratio 0.19 (95% confidence interval 0.06 to 0.63)] and SP-artesunate [Hazard Ratio 0.25 (95% confidence interval 0.10 to 0.65)] compared with SP monotherapy. With one exception (an abortion in the SP-azithromycin group), all adverse pregnancy outcomes could be attributed to known infectious or obstetrical causes. Because of the small sample size, the effect on birth outcomes, maternal malaria or maternal anemia could not be evaluated. CONCLUSIONS: Both SP-artesunate and SP-azithromycin appeared to be safe, well tolerated and efficacious for the treatment of malaria during pregnancy. A larger study is needed to determine their safety and efficacy in preventing poor birth outcomes. TRIAL REGISTRATION: ClinialTrials.gov NCT00287300.

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  • 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 [127]

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Cited by

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Authors
Kalilani, L., Mofolo, I., Chaponda, M., Rogerson, S. J., Alker, A. P., Kwiek, J. J., & Meshnick, S. R.
Affiliations
  • University of North Carolina at Chapel Hill (US)
  • University of Malawi (MW)
  • The University of Melbourne (AU)
Corresponding author
Kalilani, Linda
ORCID
Venue
PLoS ONE
Publisher
Public Library of Science (PLoS)
Published
2007-11-14
Volume
2
Issue
11
Pages
e1166
ISSN
1932-6203 (ISSN-L)
DOI
10.1371/journal.pone.0001166
PMC
PMC2048661
OpenAlex
W2127587232
Cited by
75
References
4
Citations by year
2026: 2 · 2025: 2 · 2024: 1 · 2023: 3 · 2022: 1 · 2021: 3 · 2020: 2 · 2019: 4 · 2018: 2 · 2017: 4 · 2016: 5 · 2015: 5 · 2014: 2 · 2013: 1 · 2012: 5
FWCI
8.27
Type
journal article
Language
en
Open access
Licence
Locations
  • PLoS ONE (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Figshare (submittedVersion, cc-by)
  • Minerva Access (University of Melbourne) (submittedVersion, cc-by)
  • Greater South Information System
Funders
  • Wellcome Trust
  • Centers for Disease Control and Prevention
  • U.S. Public Health Service (S1935-21/21)
Topics
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Malaria Research and Control
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Phytochemical compounds biological activities
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Pharmaceutical Quality and Counterfeiting
Keywords
malaria in pregnancy, Plasmodium falciparum, sulfadoxine-pyrimethamine, azithromycin, artesunate, combination antimalarial therapy, recrudescence, parasite clearance time, fever clearance time, drug resistance, adverse pregnancy outcomes, Blantyre, Malawi
MeSH terms
Artesunate, Adolescent, Adult, Female, Humans, Middle Aged, Pilot Projects, Pregnancy, Pregnancy Complications, Parasitic, Malaria, Falciparum, Azithromycin, Artemisinins

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