Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women
NCT ID: NCT00287300
Last Updated: 2006-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
141 participants
INTERVENTIONAL
2003-09-30
2005-08-31
Brief Summary
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Detailed Description
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The investigators conducted a trial to determine the efficacy and safety of azithromycin and artesunate combined with sulphadoxine-pyrimethamine as treatment against malaria during pregnancy.Pregnant women 14 to 26 weeks gestation with P. falciparum parasitemia on peripheral blood film were randomly assigned into 3 treatment groups and received two doses of:(1) SP (3 tablets) only; (2) SP and azithromycin (1gram/day x 2 days)and (3) SP and artesunate 200mg/day for 3 days). The two doses of the study drug were administered approximately 4 weeks apart. All study drugs were taken under observation.Blood samples were collected on days 1, 2, 3, 7 and 14 after treatment and at any visit when the women presented with symptoms of malaria. The women were also given an insecticide-treated net (ITN) and followed until delivery. Adverse effects were assessed at each scheduled visit, any unscheduled visits during the study, and at delivery. Peripheral and placental blood films and placental biopsies were prepared at delivery. Newborns were weighed, examined, and gestational age was determined.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Interventions
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Sulfadoxine-Pyrimethamine
Azithromycin
Artesunate
Eligibility Criteria
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Inclusion Criteria
* signed informed consent
* age 15-49 years
* mother has felt the movements of the foetus (quickening)
* fetal age of at least 14 but not more than 26 completed gestation weeks
* maternal availability for follow-up during the entire period of the study
Exclusion Criteria
* mental disorder that may affect comprehension of the study or success of follow-up
* twin pregnancy
* pregnancy complications evident at enrollment visit (moderate to severe oedema, blood Hb concentration \< 7 g / dl, systolic blood pressure (BP) \> 160 mmHg or diastolic BP \> 100 mmHg)
* prior receipt of azithromycin during current pregnancy
* receipt of any antimalarial within 28 days before enrollment
* known allergy to drugs containing sulfonamides, macrolides or pyrimethamine
* history of anaphylaxis
* history of any serious allergic reaction to any substance, requiring emergency medical care
* history of hepatitis or jaundice
* concurrent participation in any other clinical trial
15 Years
49 Years
FEMALE
No
Sponsors
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Centers for Disease Control and Prevention
FED
University of North Carolina
OTHER
Principal Investigators
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Steve R Meshnick, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
2. Department of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill NC USA
Stephen J Rogerson, MB BS, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
3. Department of Medicine, University of Melbourne, Royal Melbourne Hospital, Parkville Victoria Australia
Marjorie Chaponda, MB BS, MPH
Role: PRINCIPAL_INVESTIGATOR
1. UNC Malaria Project, Department of Community Health, College of Medicine, University of Malawi
Locations
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Mpemba and Madziabango Health Centers
Blantyre, , Malawi
Countries
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References
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Kalilani L, Mofolo I, Chaponda M, Rogerson SJ, Alker AP, Kwiek JJ, Meshnick SR. A randomized controlled pilot trial of azithromycin or artesunate added to sulfadoxine-pyrimethamine as treatment for malaria in pregnant women. PLoS One. 2007 Nov 14;2(11):e1166. doi: 10.1371/journal.pone.0001166.
Other Identifiers
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03-EPID-153
Identifier Type: -
Identifier Source: org_study_id