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STRATIFIED HOST DIRECTED THERAPY FOR DRUG RESISTANT TUBERCULOSIS A RANDOMIZED C...

STRATIFIED HOST DIRECTED THERAPY FOR DRUG RESISTANT TUBERCULOSIS A RANDOMIZED CONTROLLED MULTI CENTRE TRIAL Tuberculosis is a leading cause of morbidity and mortality worldwide. Current TB treatments are inadequate, requiring patients closely adhere to multi-drug regimens that are long, complex, and often poorly tolerated. These concern... ver más

31/12/2025

SWISS TPH SWISS TR...

10M€

Presupuesto del proyecto: 10M€

Líder del proyecto

SCHWEIZERISCHES TROPEN UND PUBLIC HEALTH INST... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Fecha límite participación Sin fecha límite de participación.

Ver 14 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2019-12-19

SC1-BHC-14-2019: Stratified host-directed approaches...

I+D

Cerrada hace 6 años

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Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

14 Participantes

SWISS TPH SWISS TROPICAL AND...

1.77M€ | Lider

INGENIERIA ALPACA

120.00K€ | Participante

FZB

316.25K€ | Participante

"INSTITUTIA MEDICO-SANITARA...

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Duración del proyecto: 72 meses Fecha Inicio: 2019-12-19
Fecha Fin: 2025-12-31

Líder del proyecto

SCHWEIZERISCHES TROPEN UND PUBLIC HEALTH INST... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 10M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto Tuberculosis is a leading cause of morbidity and mortality worldwide. Current TB treatments are inadequate, requiring patients closely adhere to multi-drug regimens that are long, complex, and often poorly tolerated. These concerns are greatly magnified in rifampicin-resistant (RIF-R) TB, an urgent global and EU public health priority. WHO estimates that only 54% of patients who began RIF-R TB treatment in 2016 were cured. In addition to these well-recognized shortcomings, current TB treatments, particularly those for RIF-R TB, leave a majority of cured patients with permanent, clinically significant lung impairment and radiographic evidence of bronchiectasis and fibrosis. This project will determine if two adjunctive host-directed therapies (HDTs) can prevent these poor outcomes. 330 patients with RIF-R TB and baseline risk factors for poor outcome will be enrolled in a randomized, controlled, 3-armed multi-centre trial, with clinical sites in Romania, Moldova, Georgia, Mozambique, and South Africa. All patients will receive standard multidrug therapy according to national guidelines. Those patients randomized to the experimental arms will in addition receive either CC-11050 or metformin. These selected HDT candidates represent 2 complementary HDT strategies: reducing inflammation vs inducing host cell anti-microbial activity, respectively. Both candidates are supported by data from preclinical and clinical studies. Co-primary efficacy endpoints will examine effects on lung function (measured by spirometry) and infection (measured as time to stable sputum culture conversion). A sub-study will examine quantitative change in lung radiodensity by CT scan. If successful, this ground-breaking project will increase Europe’s capacity to control RIF-R-TB by developing new treatments that increase the likelihood of cure and reduce the risk of life-long disability.

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