Health TrialsbyHealthPanel

ESAT6/CFP10 Skin Testing for TB Infection in Rheumatologic Patients

ConditionTuberculosis (TB)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorChinese University of Hong Kong

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

diagnosis of active TB diseases,

currently receiving TB or LTBI treatment;

concurrent mental illnesses;

prisoners.

Trial 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)

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: study group1 intervention

Trial outcomes

Primary outcomes

1

C-TST reading

Concordance between C-TST and standard TST

Time frame
from enrolment to reading test result at 48-72 hours
2

C-TST reading

Concordance between C-TST and IGRA test result

Time frame
from enrolment to reading test result at 2 weeks

Secondary outcomes

1

Proportion with TB disease

Proportion of patients by test results who developed TB disease

Time frame
from enrolment to last followup at 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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