ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ESAT6/CFP10 skin test.
- Who it may be relevant to
- Registry conditions: Tuberculosis (TB). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China, Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Use of a Novel ESAT6/CFP10 Skin Test in Diagnosis of Latent Tuberculosis Infection Among Rheumatologic Patients
Overview
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.
Interventions
- Diagnostic test 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.
Primary outcome measures
- C-TST reading [Time frame: from enrolment to reading test result at 48-72 hours]
- C-TST reading [Time frame: from enrolment to reading test result at 2 weeks]
Secondary outcome measures (1)
- Proportion with TB disease [Time frame: from enrolment to last followup at 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- diagnosis of active TB diseases,
- currently receiving TB or LTBI treatment;
- concurrent mental illnesses;
- prisoners.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- S.H. Ho Research Centre for Infectious Diseases — Hong Kong
Hong Kong · 1 center
- S.H. Ho Research Centre for Infectious Diseases — Shatin
Identifiers
NCT: NCT06796647 · HMRF23220212