Immunological Biomarkers in Tuberculosis Management (OPTI-4TB)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Tuberculosis; Tuberculosis Infection

Treatments: Other: Single blood sample; Other: Multiple blood samples

Study type: Interventional

Funder types: Other

Identifiers

NCT04271397

69HCL18_0757

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Active tuberculosis

Other group

Treatment:

Other: Multiple blood samples

Latent tuberculosis infection

Other group

Treatment:

Other: Single blood sample