Efficacy and Safety of Azithromycin and Artesunate in Pregnant Women

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare the efficacy and safety of three treatment regimens for the prevention of malaria during pregnancy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina
• Collaborator: Centers for Disease Control and Prevention
• Treatments: Artemisinins; Artesunate; Azithromycin; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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