RecruitingNCT06796647

ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients

The Use of a Novel ESAT6/CFP10 Skin Test in Diagnosis of Latent Tuberculosis Infection Among Rheumatologic Patients

Sponsor

Chinese University of Hong Kong

Enrollment

100 participants

Start Date

Mar 19, 2025

Study Type

OBSERVATIONAL

Conditions

Tuberculosis (TB)

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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

Exclusion Criteria4

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

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Interventions

DIAGNOSTIC_TESTESAT6/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.