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