Descripción del proyecto
Mejora de la lucha contra la fiebre de Lassa en Nigeria
La fiebre de Lassa (FL) es una enfermedad grave con una elevada tasa de mortalidad entre los pacientes hospitalizados en África Occidental. En la actualidad, no existe ningún tratamiento seguro y eficaz para esta enfermedad, a excepción de la ribavirina, cuya administración es cuestionada por algunos expertos. La aplicación de un tratamiento eficaz contra la FL reduciría sus tasas de mortalidad y aliviaría sus repercusiones socioeconómicas. Nigeria es el país más afectado por la FL, con el 80 % de todos los casos a nivel mundial. El proyecto INTEGRATE, financiado con fondos europeos, tiene por objeto crear una plataforma de ensayos clínicos para evaluar fármacos nuevos y readaptados en Nigeria y otros países afectados por la FL. Al facilitar la transferencia de tecnología y la formación Norte-Sur y Sur-Sur, el proyecto pretende mejorar la capacidad de los centros, laboratorios y centros de atención médica.
Objetivo
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.
Ámbito científico
Palabras clave
Programa(s)
- HORIZON.2.1 - Health Main Programme
Convocatoria de propuestas
Consulte otros proyectos de esta convocatoriaRégimen de financiación
HORIZON-JU-RIA - HORIZON JU Research and Innovation ActionsCoordinador
33000 Bordeaux
Francia