Efficacy of Combination Therapy for Prevention of Effects of Malaria During Pregnancy

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study is an investigation to compare the efficacy of two different intermittent sulfadoxine/pyrimethamine (SP) treatment regimens and intermittent sulfadoxine/pyrimethamine (SP) + artesunate (SP/AS) treatment of HIV negative and positive mothers in clearing placental parasitemia at delivery. If intermittent protective SP/AS treatment is equally efficacious and safe as intermittent protective SP, such a regimen could be adapted for programmatic use as a potentially more durable alternative to SP monotherapy in areas of increasing SP resistance.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Centers for Disease Control and Prevention
• Collaborator: Ifakara Health Research and Development Centre
• Treatments: Artesunate; Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• Women 15 years of age or older

• First or second pregnancy between 16 and 36 weeks gestation

Exclusion Criteria:

• Pregnancy prior to 16 weeks or after 36 weeks gestation

• Third or later pregnancy;

• Report previous allergic reactions to SP, AS, or unknown antimalarials;

• If the distance to their home is too great or too inaccessible for follow-up;

• Child's father refuses the woman's participation