RECRUITINGINTERVENTIONAL

Immunological Biomarkers in Tuberculosis Management

Optimization of Tuberculosis Diagnosis and Management Using Four Immunological Biomarkers

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: Adult ≥ 18 year-old - Patients having given written consent - Patients accepting a follow up ≥ 6 months - Proven active tuberculosis (positive direct examination and/or PCR) - Latent tuberculosis infection assessed by positive IGRA Who Should NOT Join This Trial: - Malignant solid tumor - Malignant hemopathy - Solid organ transplantation or hematopoietic stem cell transplantation - Immunosuppressive treatments (i.e. biologics, calcineurin inhibitors, corticosteroids) - Auto-inflammatory disease - Chronic liver diseases - Chronic infection with HIV, HCV (hepatitis C virus) or HBV (hepatitis B virus) - Antimycobacterial treatment initiated \> 7 days - Pregnancy or breastfeeding - Refusal to participate to the study - Persons deprived of their liberty by judicial or administrative decision - Protected adults - Patients not affiliated to health-care social security - The homeless Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: Adult ≥ 18 year-old * Patients having given written consent * Patients accepting a follow up ≥ 6 months * Proven active tuberculosis (positive direct examination and/or PCR) * Latent tuberculosis infection assessed by positive IGRA Exclusion Criteria: * Malignant solid tumor * Malignant hemopathy * Solid organ transplantation or hematopoietic stem cell transplantation * Immunosuppressive treatments (i.e. biologics, calcineurin inhibitors, corticosteroids) * Auto-inflammatory disease * Chronic liver diseases * Chronic infection with HIV, HCV (hepatitis C virus) or HBV (hepatitis B virus) * Antimycobacterial treatment initiated \> 7 days * Pregnancy or breastfeeding * Refusal to participate to the study * Persons deprived of their liberty by judicial or administrative decision * Protected adults * Patients not affiliated to health-care social security * The homeless

Treatments Being Tested

OTHER

Multiple blood samples

Patients with active tuberculosis will have 5 research-specific blood samples: V1, (baseline) immediately before initiating anti-tuberculosis treatment, then 4 samples during anti-tuberculosis treatment and follow-up, i.e. at 48 hours (V2), 15 days (V3), 2 months (V4) and 6 months (V5) after initiation of treatment. The total volume of each sample will be 20 mL for a total of 100 mL.

OTHER

Single blood sample

Patients with Latent tuberculosis infection will have a single specific sample of 14 mL.

Locations (1)

Service des Maladies Infectieuses - Hôpital de la Croix Rousse - Hospices Civils de Lyon

Lyon, France