ESAT6/CFP10 (C-TST) skin test to detect TB infection in rheumatology patients

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 prospective observational study in Hong Kong will recruit adults with rheumatologic diseases who are scheduled to start b/tsDMARD therapy. Participants will receive intradermal PPD RT23 on one forearm and ESAT6/CFP10 (C-TST) on the other, plus a QuantiFERON-TB Gold IGRA blood test, with skin readings at 48–72 hours. LTBI treatment will follow current clinical guidelines where indicated and participants will be clinically followed for two years. Analyses include concordance (kappa), sensitivity and specificity of C-TST versus PPD and IGRA, and decision-analytic Markov modelling to estimate clinical and economic impacts of different LTBI management strategies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. adult of age ≥ 18 and up to 65 years;
2. diagnosis of at least one classified rheumatologic disease; and
3. being planned to receive b/tsDMARDs therapy,
4. can communicate in Chinese and/or English.

Exclusion Criteria:

* diagnosis of active TB diseases,
* currently receiving TB or LTBI treatment;
* concurrent mental illnesses;
* prisoners.

Where it's running

• S.H. Ho Research Centre for Infectious Diseases
  Hong Kong, Hong Kong, China Recruiting
• S.H. Ho Research Centre for Infectious Diseases
  Shatin, Hong Kong, Hong Kong Not yet recruiting

Study contacts

• Study coordinator: Shui Shan Lee, MD
• Email: sslee@cuhk.edu.hk
• Phone: 852 22528812

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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.