Evaluation of a Novel Microbiological Diagnostic Test for Latent Mycobacterium Tuberculosis Infection

Launched by QUEEN MARY UNIVERSITY OF LONDON · Dec 10, 2024

Keywords

ClinConnect Summary

This study is exploring a new blood test to look for tiny amounts of TB bacteria (M. tuberculosis) directly in a specific type of blood cell (CD34+ cells). It’s an observational study in two groups: adults being screened for latent TB infection (LTBI) and adults newly diagnosed with active TB who are about to start standard TB treatment. Researchers will check if TB DNA can be found in blood, how this relates to the usual immune tests for TB, and whether a blood-based risk signature linked to developing active TB is present. They will also see if patterns change over time with treatment or preventive therapy. The goal isn’t to change care yet, but to learn whether this blood test could someday improve how we identify who actually needs treatment for LTBI.

Who can join? Adults 16 years or older, in two groups: (1) LTBI screenees who are undergoing routine TB screening (for example, close contacts of TB patients or people from areas with higher TB risk), and (2) adults with recently diagnosed active TB about to start treatment. Exclusion criteria include known HIV infection, previous treatment for active TB or LTBI, or not starting chemoprophaxis when it’s indicated. Participants will have up to about 120 mL of blood drawn at baseline and again at about 3 months (and possibly around 6 months), plus a few standard TB tests. HIV testing is offered if not already done as part of care. Importantly, the research test results won’t guide treatment decisions during the study. The study is being run at the Blizard Institute, Queen Mary University of London, and is currently enrolling by invitation, with an expected completion around October 2026.

Gender

ALL

Eligibility criteria

• • i) For LTBI screenees
• Inclusion Criteria:
• • Age ≥16 years
• • Undergoing screening for LTBI
• • Gives written informed consent to participate
• Exclusion Criteria:
• • Known HIV infection
• • Declines HIV testing
• • Previous antimicrobial treatment for active TB or latent TB infection
• • Clinical suspicion of active TB
• • Already initiated chemoprophylaxis
• • ii) For adults with active TB Inclusion criteria
• • Age ≥16 years
• • Newly-diagnosed active TB about to initiate treatment
• • Gives written informed consent to participate
• • Exclusion criteria
• • Known HIV infection
• • Declines HIV testing
• • Already initiated anti-TB treatment
• • Haemoglobin concentration \<10 g/dl at screening