Evaluating new biomarkers for managing tuberculosis
Optimization of Tuberculosis Diagnosis and Management Using Four Immunological Biomarkers
NA · Hospices Civils de Lyon · NCT04271397
This study is testing new blood tests to see if they can help doctors better manage tuberculosis and improve treatment for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 1 site (Lyon) |
| Trial ID | NCT04271397 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the management of tuberculosis (TB) by evaluating the diagnostic accuracy and outcome prediction of four novel biomarkers. These include a double IGRA test, a whole blood transcriptomic analysis of mRNA expression, a whole blood proteomic analysis, and ex vivo immunophenotyping of lymphocyte populations. By analyzing multiple blood samples, the study seeks to enhance treatment adherence and efficacy monitoring for patients with active TB. The ultimate goal is to provide better patient care and reduce the risk of relapse and drug resistance.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with proven active tuberculosis or latent tuberculosis infection.
Not a fit: Patients with certain malignancies, chronic infections like HIV or hepatitis, or those on immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective monitoring and management of tuberculosis, improving patient outcomes.
How similar studies have performed: Other studies have explored biomarkers in TB management, but the specific combination of approaches in this study may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lyon
- Service des Maladies Infectieuses - Hôpital de la Croix Rousse - Hospices Civils de Lyon — Lyon, France (RECRUITING)
Study contacts
- Study coordinator: Florence ADER, M.D., Ph.D
- Email: florence.ader@chu-lyon.fr
- Phone: 04 72 07 11 07
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tuberculosis, Tuberculosis Infection