NCT00164255

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

Efficacy of Intermittent Sulfadoxine-Pyrimethamine and Sulfadoxine-Pyrimethamine + Artesunate Treatment in the Prevention of Malaria in Pregnancy in an Area With Chloroquine-Resistant Plasmodium Falciparum

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,614 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: Female
• Age: 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	sulfadoxine/pyrimethamine
DRUG	sulfadoxine/pyrimethamine plus artesunate

Timeline

• Start date: 2003-01-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2005-09-14
• Last updated: 2012-09-11

Locations

2 sites across 1 country: Tanzania