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Study identifier: NCT04271397 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Immunological Biomarkers in Tuberculosis Management

Condition: Tuberculosis · Tuberculosis Infection  ·  Sponsor: Hospices Civils de Lyon

PhaseNA
Planned participants60
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Florence ADER, M.D., Ph.D  ·  04 72 07 11 07  ·  florence.ader@chu-lyon.fr

Oana DUMITRESCU, M.D., PhD  ·  04 72 07 11 07  ·  oana.dumitrescu@chu-lyon.fr

Always discuss trial participation with your own doctor first.

Locations (1)

Service des Maladies Infectieuses - Hôpital de la Croix Rousse - Hospices Civils de LyonLyon, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT04271397