drugset
drugset / Trial / NCT05426434

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

NCT05426434 ↗

Phase 3 Active not recruiting 1172 enrolled Menzies School of Health Research Curtin University · collabLiverpool School of Tropical Medicine · collabPapua New Guinea Institute of Medical Research · collabUniversity of Melbourne · collab
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dihydroartemisinin-piperaquine Unknown — —
Background Sulfadoxine-pyrimethamine Small molecule — —

Indications

malaria pregnancy disorder