The PYRAPREG study held its investigators’ meeting on 9-10 March 2023 in Amsterdam, Netherlands. The study is a phase III open-label, multicentre, randomized, non-inferiority clinical trial comparing pyronaridine-artesunate (PA) with artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) for the treatment of falciparum malaria in women in the second and third trimesters of pregnancy. The PYRAPREG study is coordinated by Prof. Kassoum Kayentao of the Université des Sciences, des Techniques et des Technologies de Bamako (USTTB), Bamako, Mali, with partners from Burkina Faso, Mozambique, the Netherlands, the Republic Democratic of Congo, Spain, The Gambia, and the United Kingdom. The study was implemented on 4 January 2021 in San/Segou and Bougoula/Sikasso (Mali), Nanoro (Burkina Faso), Lisungi (Democratic Republic of Congo), Manhiça (Mozambique), and Basse (The Gambia) and completed recruitment on 3 February 2023, achieving a sample size of 1,875 pregnant women. The last patient last visit (LPLV) is expected to occur in early January 2024.
The meeting was opened with welcome notes from Prof. Kassoum Kayentao (Project Coordinator), Dr Henk Schallig (Principal Investigator at Amsterdam UMC), and Dr Montserrat Blázquez-Domingo (EDCTP-The Hague) and gathered members from five African countries (Mali, Burkina Faso, Democratic Republic of Congo, and The Gambia) and three European countries (The Netherlands, Spain, and United Kingdom), including representatives from ClinaPharm. and Medicines Malaria Venture (MMV) as an observer.
The main objectives of the meeting focussed on study progress updates from each study site, in particular, the follow-up phase of participants; data cleaning progress; operational and strategic planning of the timelines to ensure completion of the study; financial shortfall due to the COVID-19 pandemic, and update on dissemination, exploitation and communication activities. In the morning session, each principal investigator provided an update on the study progress where all adverse events (AEs), serious adverse events (SAEs), and withdrawal were carefully analysed. The meeting concluded with presentations from the ULTRAPYRAPREG ancillary study (led by Prof. Vivi Maketa) on malaria diagnostics using ultrasensitive malaria Rapid Diagnostic tests and on the pharmacokinetic (PK) sub-study (led by Prof. Esperança Sevene) in a sub-sample of 60 participants in Mozambique and the Democratic Republic of Congo where the prevalence of HIV is higher.