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Sulfadoxine-pyrimethamine Plus Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment in Pregnancy

NCT05426434 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1172

Last updated 2025-06-06

No results posted yet for this study

Summary

This trial tests the hypothesis that intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) plus dihydroartemisinin-piperaquine (DP) significantly reduces the risk of malaria infection (primary outcome) and adverse birth outcomes (key secondary outcome) in an endemic area of Papua New Guinea (PNG), compared to IPTp with SP alone (the current standard of care).

To test this hypothesis a double-blinded, placebo-controlled, phase-III, superiority trial will individually randomize 1,172 HIV-uninfected pregnant women enrolled from 12-26 gestational weeks in equal proportions to one of two IPTp arms: 1) SP given every for weeks, or 2) SP+DP given every 4 weeks. 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

  • Malaria
  • Malaria in Pregnancy
  • Pregnancy Related

Interventions

DRUG

Dihydroartemisinin-Piperaquine (DP)

DP (D-Artepp) will be supplied by Fosun Pharma, China. DP will consist of three 40mg/320mg) tablets given once a day for three consecutive days

DRUG

Sulfadoxine pyrimethamine (SP)

SP (G-COSPE) will be supplied by Fosun Pharma, China. SP will be given as a single dose consisting of three 500mg/25mg tablets.

Sponsors & Collaborators

  • Papua New Guinea Institute of Medical Research

    collaborator OTHER_GOV

  • University of Melbourne

    collaborator OTHER

  • Curtin University

    collaborator OTHER

  • Liverpool School of Tropical Medicine

    collaborator OTHER

  • Menzies School of Health Research

    lead OTHER

Principal Investigators

  • Holger Unger, PhD MBChB · Menzies School of Health Research, Darwin, Australia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2025-03-31
Completion
2025-12-31

Countries

  • Papua New Guinea

Study Locations

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Entities

Diseases
Companies

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 NCT05426434 on ClinicalTrials.gov