ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients

NCT06796647 | Recruiting

• 1 other identifier: HMRF23220212
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 2

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.

Conditions

Tuberculosis (TB)

Keywords

tuberculosis; skin testing; ESAT6/CFP10; rheumatology patients

Outcome Measures

Primary Outcomes (2)

• C-TST reading

  Concordance between C-TST and standard TST

  from enrolment to reading test result at 48-72 hours

• C-TST reading

  Concordance between C-TST and IGRA test result

  from enrolment to reading test result at 2 weeks

Secondary Outcomes (1)

• Proportion with TB disease

  from enrolment to last followup at 2 years

Study Arms (1)

study group

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

Diagnostic Test: ESAT6/CFP10 skin test

Interventions

ESAT6/CFP10 skin test 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.

study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rheumatology patients followed up at the Specialist Services of regional hospitals in New Territories East Cluster in Hong Kong (Prince of Wales Hospital, Alice Ho Miu Ling Nethersole Hospital and North District Hospital)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

S.H. Ho Research Centre for Infectious Diseases

Hong Kong, Hong Kong, 0000, China

RECRUITING

S.H. Ho Research Centre for Infectious Diseases

Shatin, Hong Kong, 0000, Hong Kong

NOT YET RECRUITING

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• David SC Hui, MD

  Chinese University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Shui Shan Lee, MD

CONTACT

852 22528812; sslee@cuhk.edu.hk

Ho So, FRCP

CONTACT

852 3505 3139; hoso@cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: March 19, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); HK (1)