Trial intelligence / Profile preview

SAPOT: SP + DP for Malaria Prevention in Pregnancy

NCT05426434Phase 3

Key facts

Status: Active, not recruiting
Start: Aug 2022
Primary completion: Mar 2025
Countries: 1
Sponsor: Menzies School of Health Research
Modality: Bivalent/Multivalent Binders, Nucleic Acid-Directed Small Molecules, Orthosteric Ligands

Drugs: dihydroartemisinin + piperaquine
Conditions: malaria

Overview

Phase 3, randomised, double-blind trial of dihydroartemisinin + piperaquine in malaria (2 arms), sponsored by Menzies School of Health Research. Primary endpoint: Malaria infection in pregnancy. Started Aug 2022; status: active, not recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

SP + DP placebo
Standard of Care: Sulfadoxine-pyrimethamine every 4 weeks + DP placebo.
SP + DP
Intervention: Sulfadoxine-pyrimethamine + Dihydroartemisinin-piperaquine every 4 weeks.

Who it enrols

Pregnant women (12-26 weeks) in Papua New Guinea, HIV-negative, without chronic medical conditions or multiple pregnancies.

Endpoints

Primary

Malaria infection in pregnancyFrom 2 weeks post-dose to delivery

Secondary

Adverse pregnancy outcomeDelivery to 28 days postpartum
Clinical malaria during pregnancyFrom 2 weeks post-dose to delivery
Composite placental malariaAt delivery
Birth weightAt delivery
Low birth weight (LBW)At delivery
Preterm birth (PTB)At delivery
Maternal anemia during pregnancy and at delivery6 months from randomisation

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