SMA-TB | A novel Stratified Medicine Algorithm to predict treatment responses to host-directed therapy in TB patients.

Summary
Tuberculosis (TB) is a chronic, life-threatening infectious disease which poses a tremendous challenge for physicians, researchers and Health Systems, which treatment is long, based only on the drug susceptibility of the responsible infective strain and very costly in drug-resistant cases (MDR-TB). The European Region still has the highest prevalence of MDR-TB in the world. Host-Directed Therapies (HDT) have been recently proposed to shorten treatment length and by to improve the patients’ outcomes while not increasing the risk of generating drug resistance.
As hyperinflammation is responsible of the lung damage associated to patients’ worse outcomes and sequelae, one of the approaches is to add an HDT with anti-inflammatory effect to the current drug regimen to cure the patients faster while having less permanent lung damage. Because TB has a wide range of clinical forms and severity stages, any therapeutic regimen needs to be studied in clinical trials (CT) as its benefit might differ among patients. No individualized personalized medicine is possible without stratifying the patients by integrating pathogen and host factors that will predict the course of the disease and the response to the intervention.
SMA-TB objectives are:
• To evaluate in a CT the potential impact of acetylsalicylic acid (ASA) and Ibuprofen (Ibu) (anti-inflammatoriesy HDT) as adjuncts to standard therapy for drug sensitive (DS-) and MDR-TB. This potentially will reduce tissue damage, decrease the length of the treatment and the risk of bad outcomes.
• To identify and clinically validate host and pathogen biomarkers for further selection according to their relevance in terms of their ability to predict TB course and outcomes and response to treatment thanks to data science protocol.
• To generate a medical algorithm to stratify patients using network-based mathematical modelling for predicting the course of the disease and its response to the intervention, to be applied during clinical management to improve and personalize TB.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/847762
Start date: 01-01-2020
End date: 31-12-2024
Total budget - Public funding: 6 388 104,00 Euro - 6 388 104,00 Euro
Cordis data

Original description

Tuberculosis (TB) is a chronic, life-threatening infectious disease which poses a tremendous challenge for physicians, researchers and Health Systems, which treatment is long, based only on the drug susceptibility of the responsible infective strain and very costly in drug-resistant cases (MDR-TB). The European Region still has the highest prevalence of MDR-TB in the world. Host-Directed Therapies (HDT) have been recently proposed to shorten treatment length and by to improve the patients’ outcomes while not increasing the risk of generating drug resistance.
As hyperinflammation is responsible of the lung damage associated to patients’ worse outcomes and sequelae, one of the approaches is to add an HDT with anti-inflammatory effect to the current drug regimen to cure the patients faster while having less permanent lung damage. Because TB has a wide range of clinical forms and severity stages, any therapeutic regimen needs to be studied in clinical trials (CT) as its benefit might differ among patients. No individualized personalized medicine is possible without stratifying the patients by integrating pathogen and host factors that will predict the course of the disease and the response to the intervention.
SMA-TB objectives are:
• To evaluate in a CT the potential impact of acetylsalicylic acid (ASA) and Ibuprofen (Ibu) (anti-inflammatoriesy HDT) as adjuncts to standard therapy for drug sensitive (DS-) and MDR-TB. This potentially will reduce tissue damage, decrease the length of the treatment and the risk of bad outcomes.
• To identify and clinically validate host and pathogen biomarkers for further selection according to their relevance in terms of their ability to predict TB course and outcomes and response to treatment thanks to data science protocol.
• To generate a medical algorithm to stratify patients using network-based mathematical modelling for predicting the course of the disease and its response to the intervention, to be applied during clinical management to improve and personalize TB.

Status

SIGNED

Call topic

SC1-BHC-14-2019

Update Date

26-10-2022
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Horizon 2020
H2020-EU.3. SOCIETAL CHALLENGES
H2020-EU.3.1. SOCIETAL CHALLENGES - Health, demographic change and well-being
H2020-EU.3.1.3. Treating and managing disease
H2020-EU.3.1.3.0. Cross-cutting call topics
H2020-SC1-2019-Two-Stage-RTD
SC1-BHC-14-2019 Stratified host-directed approaches to improve prevention, treatment and/or cure of infectious diseases