Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) + dihydroartemisin-piperaquine (DP) will significantly reduce the risk of adverse birth outcomes compared to IPTp with SP alone or DP alone. This double-blinded randomized controlled phase III trial of 2757 HIV uninfected pregnant women enrolled at 12-20 weeks gestation will be randomized in equal proportions to one of three IPTp treatment arms: 1) SP given every 4 weeks, or 2) DP given every 4 weeks, or 3) SP+DP given every 4 weeks. SP or DP placebos will be used to ensure adequate blinding is achieved in the study and follow-up will end 28 days after giving birth.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Grant Dorsey, M.D, Ph.D.
• Collaborators: Infectious Diseases Research Collaboration, Uganda; National Institutes of Health (NIH)
• Treatments: Artenimol; Dihydroartemisinin; Fanasil, pyrimethamine drug combination; Piperaquine; Pyrimethamine; Sulfadoxine

Criteria

Inclusion Criteria:

1. Viable singleton pregnancy confirmed by ultrasound

2. Estimated gestational age between 12-20 weeks

3. Confirmed to be HIV- uninfected by rapid test

4. 16 years of age or older

5. Residency within Busia District of Uganda

6. Provision of informed consent

7. Agreement to come to the study clinic for any febrile episode or other illness and avoid medications given outside the study protocol

8. Willing to deliver in the hospital

Exclusion Criteria:

1. History of serious adverse event to SP or DP

2. Active medical problem requiring inpatient evaluation at the time of screening

3. Intention of moving outside of Busia District Uganda

4. Chronic medical condition requiring frequent medical attention

5. Prior chemopreventive therapy or any other antimalarial therapy during this pregnancy

6. Early or active labor (documented by cervical change with uterine contractions)

7. Multiple pregnancies (i.e. twins/triplets)