NCT06796647 ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients
| NCT ID | NCT06796647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Tuberculosis (TB) |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-19 |
| Primary Completion | 2028-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-03-19 with a primary completion date of 2028-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of the study is to pilot the application of a novel ESAT6/CFP10 (C-TST) skin test in rheumatologic disease patients prior to initiation of treatment with biologic and/or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARD). This is a prospective observational study involving the recruitment of patients with rheumatologic diseases who are planned for initiation of b/tsDMARD. Eligible patients would undergo skin testing by the Mantoux technique with purified protein derivative (PPD) RT23 on one forearm and C-TST on the other, alongside routine blood sampling for Interferon-Gamma Release Assay. The skin test results would be read within 48-72 hours afterwards. Treatment of TB infection would be provided in accordance with current clinical guidelines, followed by regular clinical monitoring for 2 years. Analyses involve performance evaluation of C-TST, and decision-analytical modelling incorporating multiple Markov process to evaluate the impact of management by LTBI testing methods on clinical outcomes and health care costs.
Eligibility Criteria
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.
Contact & Investigator
David SC Hui, MD
STUDY DIRECTOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06796647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Tuberculosis (TB). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06796647 currently recruiting?
Yes, NCT06796647 is actively recruiting participants. Contact the research team at sslee@cuhk.edu.hk for enrollment information.
Where is the NCT06796647 trial being conducted?
This trial is being conducted at Hong Kong, China, Shatin, Hong Kong.
Who is sponsoring the NCT06796647 clinical trial?
NCT06796647 is sponsored by Chinese University of Hong Kong. The principal investigator is David SC Hui, MD at Chinese University of Hong Kong. The trial plans to enroll 100 participants.