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

Informations projet

PYRAPREG-extended

N° de convention de subvention: 101145638

DOI

10.3030/101145638

Projet clôturé

Date de signature de la CE 26 Avril 2024

Date de début 1 Mai 2024

Date de fin 30 Avril 2025

Financé au titre de

• Health

Coût total

€ 1 539 644,56

Contribution de l’UE

€ 1 539 644,56

Coordonné par

STICHTING AMSTERDAM UMC
Netherlands

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Websites, patent fillings, videos etc. (1)

Website update

Update website with Pyrapreg extension overview and consortium; website will subsequently be updated in M3, 6, 9 and 12.

Other (1)

Organization of project progress and final meeting(s)

Meetings + minutes (either through monthly teleconference of face-to-face meetings) to monitor the implementation and progress of the project

Documents, reports (18)

Data Safety and Monitoring Board (DSMB) meetings

Organization and minuting of DSMB meetings

Final Stewardship Plan

Stewardship plans outline how to achieve the optimal use of an intervention, including, for example, how to avoid irrational use, overuse or abuse of health technologies.” A final plan will be made availabe in M12

Clinical Trial Report

This is the report of the clinical activities and will include the end of follow up report of both mothers and infants.

Stewardship plan

Stewardship plans outline how to achieve the optimal use of an intervention, including, for example, how to avoid irrational use, overuse or abuse of health technologies.” A draft plan will be made available in M6.

Updated plan for the exploitation and dissemination of results including communication activities

We will reassess our previous developed Plan for the exploitation and dissemination of results including communication activities for compliance with Horizon Europe requirements. An updated version will be available at M6

Collection of documents related to the status of the clinical trial

deliverable Provision of EDCTP2 project documents to be shared as background information. These include:-Initial study package of Pyrapreg-Final version of study protocol-Ethical approvals-Data and Safety Monitoring Board reports-Publications

Master Degrees (2)

Two Masters students have completed their training.

Maternal Safety Report

Report on maternal AE, AESI and SAE

Networking Progress Report

List of updates in the dissemination tools.

PhD Degrees (2)

Two PhD students have completed their PhD training

Trail Steering Committee (TSC) meetings

Organization and minuting of TSC meetings

Updated Data Management Plan

The MRC-The Gambia of LSTMH is responsible for the data management of the project. A data management plan (DMP) has been put in place under EDCTP 2. An updated DMP will be made available at M6.

Study final report

This is the overall report of the entire study including all the different work packages.

Final report

Report describing the final outcomes of the project as per EU regulations

Population PK Report

Summary report on the population PK and PKPD modelling of pyronaridine in pregnant and non-pregnant malaria patients, including pregnancy effects and exposure-response analysis

Report on the status of posting results

Report on the posting of summary trial results in the applicable registry/ies (where the study was registered).

Infant Safety Report

Safety outcome after one year.

Global Access Plan

Proportional global access plan describing potential registration and access items

Ethics Requirements (1)

OEI - EPQ - Requirement No. 1

Ethics Advisor: An external independent ethics advisor needs to be appointed to advise the project participants on ethics issues, in particular the need to address ethical risks related to the involvement of vulnerable populations (pregnant women and children) in the research and to ensure that their interests are adequately protected. The ethics advisor should have expertise in research ethics in general and substantial experience in the assessment of ethics issues in the specific topic area of this project.An ethics report by ethics external advisor should be provided.

Publications

Peer reviewed articles (3)

Impact of malaria in pregnancy on infant neurodevelopment and malaria susceptibility during the first year of life in Kinshasa, the Democratic Republic of the Congo

Auteurs: Japhet Kabalu Tshiongo, Lise Kuseke, Thierry Kalonji, Patrick Mitashi, Aimée Mupuala, Kassoum Kayentao, Trésor Zola Matuvanga, Vivi Maketa Tevuzula, Yann Kafala, Henk D.F.H. Schallig, Hypolite Muhindo Mavoko, Petra F. Mens
Publié dans: International Journal of Infectious Diseases, 2025, ISSN 1201-9712
Éditeur: Elsevier BV
DOI: 10.1016/J.IJID.2025.107927

Congenital malaria in newborns of mothers living in highly endemic parts of Kinshasa, Democratic Republic of Congo

Auteurs: Japhet Kabalu Tshiongo, Lise Kuseke, Vivi Maketa Tevuzula, Flory Luzolo, Yann Kafala, Evodie Ngelesi, Moussa Djimde, Patrick Mitashi, Thierry Kalonji-Mukendi, Damien Mbanzulu Pita Nsonizau, Kassoum Kayentao, Petra F. Mens, Ryan van den Bos, Hypolite Muhindo Mavoko, Henk D. F. H. Schallig
Publié dans: Paediatrics and International Child Health, 2025, ISSN 2046-9047
Éditeur: Informa UK Limited
DOI: 10.1080/20469047.2025.2459964

Importance of Lysosomal Trapping and Plasmodium Parasite Infection on the Pharmacokinetics of Pyronaridine: A Physiologically Based Pharmacokinetic Model-Based Study

Auteurs: Wan-Yu Chu, Wietse M. Schouten, Hypolite Muhindo Mavoko, Japhet Kabalu Tshiongo, Doudou Malekita Yobi, Freddy-Arnold Kabasele, Gustave Kasereka, Vivi Maketa, Esperança Sevene, Anifa Vala, Jangsik Shi
Publié dans: Clinical Pharmacokinetics, 2025, ISSN 0312-5963
Éditeur: Springer Science and Business Media LLC
DOI: 10.1007/S40262-025-01581-6