Immunological Biomarkers in Tuberculosis Management

Launched by HOSPICES CIVILS DE LYON · Feb 12, 2020

Keywords

ClinConnect Summary

**Trial Summary: Immunological Biomarkers in Tuberculosis Management**

This clinical trial is focused on improving how we diagnose and monitor treatment for tuberculosis (TB), a serious infection that causes a significant number of deaths worldwide. Researchers are testing four new methods, called biomarkers, that could help us better understand how well a patient is responding to TB treatment and if they are following their prescribed medication regimen. These methods involve analyzing blood samples to look for specific genetic and protein markers that indicate active TB. The goal is to find faster and more reliable ways to ensure patients are receiving effective care, which is especially important given the lengthy treatment process and potential side effects.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of active tuberculosis or a positive test for latent TB. Those who are pregnant, have certain serious health conditions, or have recently started TB treatment may not be eligible. Participants will need to commit to follow-up visits for at least six months to help researchers gather important information. If you choose to join this study, you will play a vital role in helping to improve TB management for future patients.

Gender

ALL

Eligibility 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