CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,757 enrolled
Drug / intervention
Sulfadoxine-pyrimethamine (SP) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04336189
NCT04336189Phase 3Completed
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Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda

Grant Dorsey, M.D, Ph.D.·interventional·Posted Apr 7, 2020·Updated Nov 6, 2025

In Brief

A Phase 3 clinical trial evaluating Sulfadoxine-pyrimethamine (SP) and Dihydroartemisinin-piperaquine (DP) for Malaria. Completed, enrolled 2,757 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesUganda
CollaboratorsNational Institutes of Health (NIH), Infectious Diseases Research Collaboration, Uganda

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedApr 7, 2020
Enrollment StartDec 28, 2020
Primary CompletionJul 28, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.2 years ago

Interventions

Sulfadoxine-pyrimethamine (SP)drug

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.

Dihydroartemisinin-piperaquine (DP)drug

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.