Informations générales (source: ClinicalTrials.gov)
Optimization of Tuberculosis Diagnosis and Management Using Four Immunological Biomarkers (OPTI-4TB)
Interventional
N/A
Hospices Civils de Lyon (Voir sur ClinicalTrials)
septembre 2019
octobre 2026
13 août 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Service des Maladies Infectieuses - Hôpital de la Croix Rousse - Hospices Civils de Lyon - 69004 - Lyon - France | Florence ADER, M.D., Ph.D. | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
- 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