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Optimization of Tuberculosis Diagnosis and Management Using Four Immunological Biomarkers
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Service des Maladies Infectieuses - Hôpital de la Croix Rousse - Hospices Civils de Lyon
Lyon, France
Start Date
September 30, 2019
Primary Completion Date
September 10, 2026
Completion Date
October 10, 2026
Last Updated
August 12, 2024
60
ESTIMATED participants
Multiple blood samples
OTHER
Single blood sample
OTHER
Lead Sponsor
Hospices Civils de Lyon
NCT06192160
NCT05947890
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05989802