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SAFETY OF ANTIMALARIALS IN THE FIRST TRIMESTER AN ADAPTIVE PLATFORM TRIAL

Background: Malaria in pregnancy can have devastating consequences, particularly in early pregnancy. Effective treatment in the first trimester can significantly improve maternal and pregnancy outcomes. However, first-trimester pr... ver más

30/11/2028

Líder desconocido

5M€

Presupuesto del proyecto: 5M€

Líder del proyecto Líder desconocido

Fecha límite participación Sin fecha límite de participación.

Financiación concedida El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2024-03-11

HORIZON-JU-GH-EDCTP3-2023-01-05: Strengthening ethics and regulatory... Expected Impact:Expected impacts of the calls under the 2023 work programme of the Global Health EDC...

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Duración del proyecto: 56 meses Fecha Inicio: 2024-03-11
Fecha Fin: 2028-11-30

Líder del proyecto Líder desconocido

Presupuesto del proyecto 5M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto Background: Malaria in pregnancy can have devastating consequences, particularly in early pregnancy. Effective treatment in the first trimester can significantly improve maternal and pregnancy outcomes. However, first-trimester pregnancies are generally excluded from clinical trials resulting in new and effective antimalarials being withheld from use in early pregnancy. WHO updated its guidelines in 2022 from quinine to artemether-lumefantrine (AL) as the first-line treatment for uncomplicated malaria in the first trimester. However, there are insufficient data on the benefit-harm of other widely used artemisinin-based combination therapies. Objectives: 1) To generate robust evidence on the safety, tolerability, and efficacy of antimalarials for the treatment of uncomplicated P. falciparum malaria in the first trimester. 2) Translate research findings into treatment guidelines and clinical practice. Study design: a) Phase IIIb, non-inferiority, Bayesian adaptive randomised platform trial comparing pyronaridine-artesunate (PA) and AL in Burkina Faso, Kenya and Mali. Primary outcome: Safety. Secondary outcomes: efficacy and tolerability. b) Formative research to inform innovative trial recruitment and retention strategies, c) Acceptability and feasibility to assess values and preferences of antimalarials during early pregnancy, d) implementation research to explore factors affecting implementation of AL in the first trimester to inform translation strategies, and e) cost-effectiveness of PA vs AL. Impact: The trial will provide critical information on the safety and efficacy of alternatives to AL for treatment in the first trimester, benefiting settings where AL is not used and aligning with WHO's strategy of multiple first-line therapies against antimalarial drug resistance. Results will be translated into policy and guidelines and ultimately ensure that healthcare providers and pregnant women have access to optimal treatment options for malaria in early pregnancy.

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