Immunological Biomarkers in Tuberculosis Management

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Hospices Civils de Lyon
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Updated on 16 February 2024
See if I qualify
antibiotics
tuberculosis
interferon
latent tuberculosis
interferon-gamma release assay
immunophenotyping
curb

Summary

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.

Details
Condition Tuberculosis
Age 18years - 100years
Treatment Multiple blood samples, Single blood sample
Clinical Study IdentifierNCT04271397
SponsorHospices Civils de Lyon
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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antibiotics
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