ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients

NCT ID: NCT06796647

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2028-08-31

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.

Detailed Description

Objective. 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), with the objectives of determining its performance and the cost-effectiveness of clinical management for latent tuberculosis infection (LTBI).

Design. A prospective observational study

Setting. Rheumatology Specialist clinic services in Hong Kong

Methods. This study involves 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 intradermal injection of 2U purified protein derivative (PPD) RT23 on one forearm and 5U of C-TST on the other, alongside routine blood sampling for Interferon-Gamma Release Assay (IGRA) with QuantiFERON-TB Gold. The skin test results would be read within 48-72 hours afterwards. Treatment of LTBI 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.

Main outcome measures. Concordance between different tests for LTBI by Kappa measure; sensitivity and specificity of C-TST test estimated with current standard; proportion of new TB cases averted, discounted QALYG and ICER.

Anticipated outcome. The study would provide preliminary evidence regarding the diagnostic performance of C-TST, and impact of its utilisation for treatment decision for rheumatologic diseases patients in the prevention of active tuberculosis diseases.

Conditions

Tuberculosis (TB)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

study group

Adult patients with diagnosed rheumatologic diseases scheduled to receive b/tsDMARDs therapy

ESAT6/CFP10 skin test

Intervention Type: DIAGNOSTIC_TEST

Each recruited participant would be offered standard tuberculin skin test (TST) and ESAT6/CFP10 (C-TST) skin test on the same day or setting of clinical visit. TST and C-TST would be performed by the Mantoux technique with intradermal injection of 2U purified protein derivative-RT23 on one forearm and 5U (1.0µg/0.1 ml) of recombinant fusion protein ESAT6-CFP10 on the other forearm respectively.

Interventions

ESAT6/CFP10 skin test

Each recruited participant would be offered standard tuberculin skin test (TST) and ESAT6/CFP10 (C-TST) skin test on the same day or setting of clinical visit. TST and C-TST would be performed by the Mantoux technique with intradermal injection of 2U purified protein derivative-RT23 on one forearm and 5U (1.0µg/0.1 ml) of recombinant fusion protein ESAT6-CFP10 on the other forearm respectively.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Shui-Shan Lee, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David SC Hui, MD

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

Locations

S.H. Ho Research Centre for Infectious Diseases

Hong Kong, Hong Kong, China

Site Status: RECRUITING

S.H. Ho Research Centre for Infectious Diseases

Shatin, Hong Kong, Hong Kong

Site Status: NOT_YET_RECRUITING

Countries

China; Hong Kong

Central Contacts

Shui Shan Lee, MD

Role: CONTACT

sslee@cuhk.edu.hk

852 22528812

Ho So, FRCP

Role: CONTACT

hoso@cuhk.edu.hk

852 3505 3139

Facility Contacts

Shui Shan Lee, MD

Role: primary

sslee.ss@gmail.com

852-61703177

Ho So, FRCP

Role: backup

852-35053139

Shui Shan Lee, MD

Role: primary

sslee@cuhk.edu.hk

852 22528812

Ho So, FRCP

Role: backup

hoso@cuhk.edu.hk

852 3505 3139

Other Identifiers

HMRF23220212

Identifier Type: -

Identifier Source: org_study_id