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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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

Criteria

Inclusion Criteria:

• Pregnant women between 12-26 weeks' gestation

• 16 years of age or older

• Viable singleton intrauterine pregnancy

• Permanent resident of the study area

• Willing to adhere to scheduled and unscheduled study visit procedures

• Willing to birth in a study clinic or hospital

• Able to provide written informed consent

Exclusion Criteria:

• Multiple pregnancy (i.e. twins/triplets)

• Known heart ailment or other chronic medical condition requiring frequent hospital care

• Active medical problem requiring inpatient evaluation at the time of screening

• Severe malformations or non-viable pregnancy if observed by ultrasound

• Antimalarial therapy in the prior two weeks

• Unable to provide written informed consent

• Known allergy or contraindication to any of the study drugs

• Early or active labour

• Known HIV-positive status