Immunological Biomarkers in Tuberculosis Management

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Malignant solid tumor

Malignant hemopathy

Solid organ transplantation or hematopoietic stem cell transplantation

Immunosuppressive treatments (i.e. biologics, calcineurin inhibitors, corticosteroids)

Trial design

Treatments tested in this trial

  • Multiple blood samples
  • Single blood sample

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators