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

• Status: Not yet recruiting
• Trial end date: 2025-12-01

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.

• Phase: Phase 3

Details

• Lead Sponsor: Menzies School of Health Research
• Collaborators: Curtin University; Liverpool School of Tropical Medicine; Papua New Guinea Institute of Medical Research; University of Melbourne
• Treatments: Artenimol; Fanasil, pyrimethamine drug combination; Piperaquine; Pyrimethamine; Sulfadoxine