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

NCT04336189 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2757

Last updated 2025-11-06

Study results available
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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.

Conditions

Interventions

DRUG

Dihydroartemisinin-piperaquine (DP)

DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.

DRUG

Sulfadoxine-pyrimethamine (SP)

SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Infectious Diseases Research Collaboration, Uganda

    collaborator OTHER

  • Grant Dorsey, M.D, Ph.D.

    lead OTHER

Principal Investigators

  • Grant Dorsey, MD, PhD · University of California, San Francisco

  • Phil Rosenthal, MD · University of California, San Francisco

  • Moses Kamya, MBChB, MMed, PhD · Makerere University; Infectious Diseases Research Collaboration

  • Abel Kakuru, MBChB, PhD · Infectious Diseases Research Collaboration

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-28
Primary Completion
2024-07-28
Completion
2024-07-28
FDA Drug
Yes

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04336189 on ClinicalTrials.gov