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Clinical Trial Summary

Tuberculosis (TB) is the leading cause of death by infectious disease in the world, responsible for 1.6 million deaths in 2017. The treatment of active TB requires at least a 6-month combined antibiotic regimen and can cause heavy side effects. As a consequence, treatment adherence is not optimal, particularly in primary care settings. Rapid and reliable monitoring of anti-TB treatment adherence and efficacy is critical to provide adequate patient care and curb relapse episodes and acquired drug resistance.

Investigators propose to evaluate the performance in terms of diagnosis accuracy and outcome prediction of four new biomarkers of active TB: 1) a double IGRA (Interferon Gamma Release Assay) including QuantiFERON-Gold Plus® and HBHA; 2) a whole blood transcriptomic analysis of mRNA (messenger Ribonucleic acid) expression of a panel of 150 genes; 3) a whole blood proteomic analysis; 4) an ex vivo immunophenotyping using flow and mass cytometry to characterize the lymphocyte populations.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04271397
Study type Interventional
Source Hospices Civils de Lyon
Contact Florence ADER, M.D., Ph.D
Phone 04 72 07 11 07
Email florence.ader@chu-lyon.fr
Status Recruiting
Phase N/A
Start date September 30, 2019
Completion date April 9, 2023

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