Descrizione del progetto
Migliorare il controllo della febbre di Lassa in Nigeria
La febbre di Lassa è una malattia grave con un alto tasso di mortalità tra i pazienti ricoverati in Africa occidentale. Attualmente non esiste un trattamento sicuro ed efficace per la febbre di Lassa, a eccezione della ribavirina, che alcuni esperti mettono in discussione. L’attuazione di un trattamento efficace ridurrebbe i tassi di mortalità e allevierebbe le implicazioni socioeconomiche. La Nigeria sopporta il più alto carico di febbre di Lasso, rappresentando l’80 % dei casi globali. Il progetto INTEGRATE, finanziato dall’UE, mira a creare una piattaforma di sperimentazione clinica per valutare farmaci nuovi e riproposti in Nigeria e in altri paesi colpiti. Facilitando il trasferimento tecnologico e la formazione, sia tra nord e sud che tra i diversi paesi del sud, il progetto mira a migliorare la capacità di siti, laboratori e strutture mediche.
Obiettivo
Lassa fever (LF) is an acute febrile illness associated with bleeding, organ failure, and shock caused by Lassa virus. LF causes outbreaks in West African with in-hospital mortality up to 12%. Challenges in the clinical care of patients are multiple due to the limited availability of LF molecular diagnostics, the risk for nosocomial transmission, and the limited treatment options.There are currently no safe and effective treatment options available for LF, except ribavirin, the efficacy of which is debated. The clinical development and accessibility of effective treatment options would be a game-changer towards reducing mortality associated with this disease and limiting its socio-economic impact. Nigeria is the country by far most affected by LF in the world with about 80% of global cases.
The INTEGRATE consortium builds on a more than 15 years lasting highly successful collaboration between leading European and West African institutions focusing on the joint priority to better understand, manage, and combat LF in West Africa.
The overall objective of the INTEGRATE project is to establish a GCP-compliant adaptive clinical platform trial in West Africa (Nigeria and other countries) to test the efficacy, tolerability and safety of repurposed and novel drug candidates for the treatment of LF. To address this objective, we focus our activities on 3 specific objectives:
- to develop and implement an adaptive randomised controlled phase II-III clinical platform trial evaluating drugs with proven preclinical activity against LF.
- to build capacity for sustainable and independently conducted clinical research in West Africa by developing site, laboratory and medical care capacity through North-South and South-South technology transfer and training. This activity encompasses capacity building of the lead Nigerian institution in GCP compliant clinical trial sponsorship.
- to engage communities with the proposed work plan and to assess acceptability of the trial.
Campo scientifico
Parole chiave
Programma(i)
- HORIZON.2.1 - Health Main Programme
Meccanismo di finanziamento
HORIZON-JU-RIA - HORIZON JU Research and Innovation ActionsCoordinatore
33000 Bordeaux
Francia