Actively Recruiting
Immunological Biomarkers in Tuberculosis Management
Led by Hospices Civils de Lyon · Updated on 2024-08-12
60
Participants Needed
1
Research Sites
366 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Immunological Biomarkers in Tuberculosis Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult 18 years or older
- Patients who have given written consent
- Patients willing to accept follow-up for at least 6 months
- Proven active tuberculosis confirmed by positive direct examination and/or PCR
- Latent tuberculosis infection confirmed by positive IGRA test
You will not qualify if you...
- Malignant solid tumor
- Malignant hemopathy
- Solid organ transplantation or hematopoietic stem cell transplantation
- Immunosuppressive treatments such as biologics, calcineurin inhibitors, or corticosteroids
- Auto-inflammatory disease
- Chronic liver diseases
- Chronic infection with HIV, hepatitis C virus, or hepatitis B virus
- Antimycobacterial treatment started more than 7 days prior
- Pregnancy or breastfeeding
- Refusal to participate in the study
- Persons deprived of liberty by judicial or administrative decision
- Protected adults
- Patients not affiliated with health-care social security
- Homeless individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Service des Maladies Infectieuses - Hôpital de la Croix Rousse - Hospices Civils de Lyon
Lyon, France, 69004
Actively Recruiting
Research Team
F
Florence ADER, M.D., Ph.D
CONTACT
O
Oana DUMITRESCU, M.D., PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here