Status:
COMPLETED
Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women
Lead Sponsor:
University of North Carolina
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Malaria
Eligibility:
FEMALE
15-49 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the efficacy and safety of three treatment regimens for the prevention of malaria during pregnancy.
Detailed Description
Malaria infection during pregnancy poses substantial risk to the mother, her fetus, and the neonate. Prevention of malaria during pregnancy is vital in decreasing maternal and child mortality in Afric...
Eligibility Criteria
Inclusion
- peripheral malaria parasitemia
- 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
- known maternal tuberculosis, diabetes, kidney disease, or liver disease
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00287300
Start Date
September 1 2003
End Date
August 1 2005
Last Update
February 6 2006
Active Locations (1)
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1
Mpemba and Madziabango Health Centers
Blantyre, Malawi