Last Updated: 16/07/2025
Intermittent Preventive Treatment with DHA-piperaquine for malaria in pregnancy in areas with high sulphadoxine-pyrimethamine resistance in Africa
Objectives
The primary objective of this study is to conduct a definitive trial to determine if Intermittent Preventive Therapy in pregnancy (IPTp) with dihydroartemisinin-piperaquine (DP) is superior to the existing strategy of IPTp with sulphadoxine-pyrimethamine (SP) for controlling malaria and reducing adverse birth outcomes in areas with intense year-round malaria transmission and high SP resistance in western Kenya and southern Malawi.
Secondary objectives of this study are to:
- determine the safety of monthly IPTp-DP by conducting nested cardio monitoring studies to specifically look at whether previously documented transient QT prolongation associated with DP increases in magnitude with subsequent courses;
- conduct, on completion of the trial, a prospective meta-analysis combining the evidence from this and previous trials to provide (with >=85% power) definitive evidence whether IPTp with DP is superior to the existing strategy of IPTp with SP for controlling malaria and reducing adverse pregnancy outcomes in areas with intense year-round malaria transmission and high SP resistance;
- determine the cost- effectiveness of IPTp-DP compared to IPTp-SP; and
- determine the acceptability and feasibility of implementing IPTp-DP compared to IPTp-SP among pregnant womenand health providers.
Liverpool School of Tropical Medicine (LSTM), United Kingdom
Overall aim of this study is to provide the Malaria Policy Advisory Committee of the World Health Organization (WHO) and National Malaria Control Programmes with the definitive evidence on the efficacy, safety, operational feasibility and cost- effectiveness of IntermittentPreventive Therapy in pregnancy (IPTp) with dihydroartemisinin-piperaquine (DP). This will enable WHO to determinewhether IPTp-DP is a viable alternative strategy to the current recommendation of IPTp with sulphadoxine-pyrimethamine(SP) in moderate to high transmission areas with high parasite resistance to SP. The researcher will also take the opportunity to explore whether the resilient effect of SP on birthweight in areas with highly SP resistant P. falciparum parasites could reflect its broad antimicrobial activity and any associated effect on the gut ormaternal vaginal microbiota.
Sep 2016 — Nov 2022
$702,347
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