Efficacy and Safety of a newly registered Artemisinin-Based Combination (Pyronaridine-Artesunate - PYRAMAX®) for the treatment of uncomplicated malaria in African pregnant women - Extended: PYRAPREG-extended

Programme(s): HORIZON.2.1 - Health MAIN PROGRAMME
Topic(s): HORIZON-JU-GH-EDCTP3-2023-01-02 - Funding to successfully finalise EDCTP2-funded clinical trials that were negatively impacted by the COVID-19 pandemic

Call for proposal: HORIZON-JU-GH-EDCTP3-2023-01

Funding Scheme: HORIZON-JU-RIA - HORIZON JU Research and Innovation Actions

Grant agreement ID: 101145638

Objective

PYRAPREG-extended aims to complete PYRAPREG project (PACTR 202011812241529) that determines efficacy and safety of Pyronaridine-Artesunate (PA) - PYRAMAX®, a newly registered Artemisinin-Based Combination, to treat uncomplicated malaria in African pregnant women, and to provide the necessary information to include this treatment in guidelines for management of malaria during pregnancy. The work includes a one year follow-up of children born to women included in the trial and pharmacokinetic (PK) sub-study. In addition, this project comprises an extensive capacity building component, including the training of PhD students. PYRAPREG activities started 1 March 2019, and were expected to be completed 28 February 2024. Intense site preparations were completed, but just before start of recruitment, COVID-19 pandemic started and significantly delayed trial implementation. Participant recruitment started early 2021 and was completed in 2023, with last delivery expected in Q3 2023. Final 1-year visit of children born to women included in the trial will occur mid-2024. Furthermore, sample analysis for QC, data cleaning and statistical analysis takes another 6 months to completion, allowing final report submission 2 months later (Feb. 2025). PK component was delayed due to late initiation of recruitment for the PK cohorts of patients. Last patient recruitment in the PK cohort is ongoing and PK sampling will finish Q3 2023. Participants follow up continues until all women delivered and all babies have reached the age of 1 year. PK bioanalysis is expected to be finished by February 2024. PK data cleaning and merging with clinical efficacy and toxicity data followed by population PK and pharmacodynamic modelling activities will then be initiated which will take around 9 months, leading up to a PK report by February 2025. PhDs encountered delays: students could not travel for training, and data collection for their studies was delayed and will be completed in PYRYPREG-extended.