Descripción del proyecto
Un mejor diagnóstico de la tuberculosis en África
La tuberculosis (TB, por sus siglas en inglés) sigue siendo un importante problema de salud pública en África, agravado por métodos de diagnóstico subóptimos. La tuberculosis extrapulmonar (EPTB, por sus siglas en inglés) representa aproximadamente el 15 % de la carga de tuberculosis, cifra que se dispara a más de un tercio en las regiones donde el VIH es endémico. Los métodos de diagnóstico actuales, como GeneXpert, tienen dificultades con la EPTB, especialmente en los casos pleurales, en los que la sensibilidad se sitúa en torno al 35 %. El equipo del proyecto EPiTB aborda esta carencia urgente mediante la promoción de IRISA-TB, una prueba diagnóstica de bajo coste y que se realiza en el mismo día, diseñada específicamente para la EPTB. Esta prueba innovadora, desarrollada por una empresa emergente sudafricana, ya ha demostrado ser prometedora en ensayos clínicos y está lista para un estudio multicéntrico a gran escala en el que participarán 2 170 pacientes, lo cual allanará el camino para mejorar el diagnóstico y la atención de la tuberculosis en África.
Objetivo
Better diagnostic approaches are required to improve TB control in Africa, which is suboptimal. One neglected aspect of TB diagnosis is that of extrapulmonary TB (EPTB), which comprises ~15% of the TB caseload. However, in HIV-endemic settings over one third of cases are due to EPTB (the most common manifestation being pleural TB). Frontline same day sputum-based diagnostic tools such as GeneXpert perform poorly when using fluid derived from EPTB-specific compartments (e.g. pleural fluid). Indeed, GeneXpert sensitivity in pleural TB is ~35%. ADA, the current standard of care used in clinical practice has poor specificity, especially in pericardial TB and TB-meningitis (see preliminary data). By contrast, unstimulated interferon-gamma (not T-cell-based IGRAs that require overnight stimulation) is an excellent biomarker for the diagnosis of EPTB (confirmed in 2 meta-analyses). A South African university start-up has now developed a low-cost same-day EPTB diagnostic test (IRISA-TB), which has been evaluated and published in several small clinical trials (see main proposal) and is locked-in for scale-up dissemination in 2022. The test is CE marked, SAHPRA approved, and endorsed by the Global Fund. This proposal encompasses a large prospective multicentric study (n= 2170 patients) of IRISA-TB in various forms of EPTB (pleural, pericardial, and peritoneal TB, and TB meningitis). The proposed study (EPiTB) has excellent fidelity with the EDCTP call because it will enable “the registration of a new health technology through pragmatic effectiveness studies”, “enable uptake of results into clinical practice” and facilitate WHO endorsement. Thus, EPiTB will drive the facilitation and uptake of an important new TB diagnostic test in Africa. Importantly, an African-invented and designed test will be promoted. Indeed, innovation and the development of an African knowledge-based economy is a key priority of the EDCTP.
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
7700 Cape Town
Sudáfrica