Sulphadoxine-Pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Uganda

• Status: Withdrawn
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The effectiveness of sulfadoxine-pyrimethamine (SP) as intermittent preventive treatment in pregnancy in malaria-endemic areas the effectiveness and efficacy of SP may be compromised by increased SP resistance. This study will evaluate the efficacy of SP by giving SP to asymptomatic parasitemic pregnant women and following them to determine the rates of parasite clearance.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Centers for Disease Control and Prevention; Uganda Malaria Surveillance Project
• Treatments: Fanasil, pyrimethamine drug combination; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

• 16-26 weeks gestation based on LMP or ultrasound or fundal height

• Axillary temperature <37.5 degrees C

• Informed consent

• HIV status known and negative

• Blood smear positive for falciparum malaria

Exclusion Criteria:

• History of hypersensitivity reaction to SP or components of SP

• Axillary temperature ≥37.5 degrees C

• History of receipt of antimalarials or antibiotics with antimalarial activity* in the past month

• Residence > 30 km from the ANC clinic or unwillingness to return for follow-up visits

• Hemoglobin level < 5 gm/dL

• These medications include all antimalarials, rifampin, doxycycline, clindamycin, tetracycline, erythromycin, azithromycin, chloramphenicol.