Measuring TB DNA in blood and urine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects plasma and urine from three groups: adults newly hospitalized with diagnosed TB, adults with latent TB infection (LTBI) confirmed by TST or IGRA, and controls without TB or LTBI. Samples will undergo molecular assays to quantify MTB cell-free DNA (cfDNA) using PCR-based methods. Results will be compared to routine microbiological, histological, and clinical diagnoses to determine how well plasma and urine cfDNA levels correlate with disease status. The study excludes patients who have received effective anti-TB treatment for more than 24 hours, individuals under 18, and those with life expectancy under 12 months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* TB group: patients hospitalized for newly diagnosed TB disease.
* LTBI group: patients without TB disease, but with LTBI diagnosed by either tuberculin skin test (TST) or an interferon-gamma release assay (IGRA) blood test.
* Control group: patients or healthy volunteers without TB disease and LTBI

Exclusion Criteria:

* Initiation of an effective anti-TB treatment regimen more than 24 hours
* Aged 17 years or younger
* Life expectancy of less than 12 months

Where it's running

• Prince of Wales Hospital
  Hong Kong, Hong Kong Recruiting
• Prince of Wales Hospital
  Hong Kong, Hong Kong, Hong Kong Not yet recruiting

Study contacts

• Study coordinator: Ka Pang Chan, MBChB
• Email: chankapang@cuhk.edu.hk
• Phone: 35052211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.