Immunological Biomarkers in Tuberculosis Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multiple blood samples, Single blood sample.
- Who it may be relevant to
- Registry conditions: Tuberculosis, Tuberculosis Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Optimization of Tuberculosis Diagnosis and Management Using Four Immunological Biomarkers
Overview
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.
Interventions
- 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.
Primary outcome measures
- Concordance of the kinetics of biomarkers with the evolution of the disease [Time frame: 6 months]
Secondary outcome measures (6)
- Analytical characteristics of a combination of 2 IGRAs (QuantiFERON-TB Gold Plus (QFT-P) and HBHA) in the diagnosis / prognosis of tuberculosis disease. [Time frame: 6 months]
- Performance of an immunomonitoring test by mass or flow cytometry in the diagnosis / prognosis of tuberculosis by measuring the dynamics of the blood population of T lymphocytes over time. [Time frame: 6 months]
- Evaluate the performance of a test based on the interpretation of a transcriptomic signature in plasma in the diagnosis / prognosis of TB. [Time frame: 6 months]
- Assess the performance of a test based on the interpretation of a protein signature in the diagnosis / prognosis of tuberculosis. [Time frame: 6 months]
- Determine the achievement of target concentrations of rifampicin [Time frame: 6 months]
- Establish the rate of metabolic self-induction of rifampicin [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Service des Maladies Infectieuses - Hôpital de la Croix Rousse - Hospices Civils de Lyon — Lyon
Publications
- Goutelle S, Bahuaud O, Genestet C, Millet A, Parant F, Dumitrescu O, Ader F; Lyon TB Study Group. Exposure to Rifampicin and its Metabolite 25-Deacetylrifampicin Rapidly Decreases During Tuberculosis Therapy. Clin Pharmacokinet. 2025 Mar;64(3):387-396. doi: 10.1007/s40262-025-01479-3. Epub 2025 Jan 27. PMID 39871048
- Bahuaud O, Genestet C, Hoffmann J, Dumitrescu O, Ader F. Opti-4TB: A protocol for a prospective cohort study evaluating the performance of new biomarkers for active tuberculosis outcome prediction. Front Med (Lausanne). 2022 Sep 14;9:998972. doi: 10.3389/fmed.2022.998972. eCollection 2022. PMID 36186786
Identifiers
NCT: NCT04271397 · 69HCL18_0757