Tuberculosis (TB) Screening for the Diagnosis of Latent TB in Immunocompromised Populations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-01-31

Study Completion Date

2005-04-30

Brief Summary

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The tuberculin skin test (TST) has been the gold standard for diagnosing latent tuberculosis for almost 100 years. While this test performs reasonably well in healthy, non-bacille Calmette-Guerin (BCG) vaccinated populations, it is believed to perform less well in patients who do not have intact cellular immune systems (immunocompromised).

The investigators hypothesize that a new test, the T-SPOT TB ELISPOT test will provide a more accurate measurement of latent infection in immunocompromised people. This study will compare the TST to the T-SPOT TB ELISPOT test, and to the results of an expert physician diagnostic panel.

Detailed Description

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Main Study Question:

We propose to investigate the correlation between the traditional TST-based method of screening for latent tuberculosis infection in specific immunocompromised populations as recommended by Canadian and American standards: the T-SPOT TB ELISPOT test: and an expert tuberculosis physician panel incorporating the Mantoux test, a risk factor survey, and a chest radiograph.

Secondary Study Question:

In a subset of patients who have tested positive on both the Mantoux and T-SPOT ELISPOT tests prior to undergoing additional immune suppression i.e., patients pre-bone marrow transplant and rheumatology patients pre-receipt of anti-TNF alpha therapy or high dose corticosteroids, we propose to repeat the T-SPOT ELISPOT and Mantoux after immune suppression to assess the development of cutaneous anergy.

Conditions

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Tuberculosis

Keywords

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tuberculosis tuberculin test immunologic tests Latent tuberculosis end stage renal disease solid organ transplantation bone marrow transplantation rheumatologic disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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T-SPOT TB ELISPOT test

ELISPOT test for detecting T cell responses to tuberculosis antigens.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants can be enrolled regardless of race, gender, risk of exposure to TB, metabolic disorders or coinfection with non-TB agents.
* Only participants who have provided written informed consent will be included.
* Patients belonging to the four following groups will be considered eligible for tuberculosis screening and inclusion in the T-SPOT ELISPOT study:

* Patients with end stage renal disease receiving hemodialysis or peritoneal dialysis;
* Recipients of solid organ transplants;
* Recipients of, or candidates for, an allogeneic stem cell transplant for hematologic malignancies;
* Patients with rheumatologic diseases (e.g., systemic lupus erythematosus \[SLE\], rheumatoid arthritis, psoriasis) who are receiving, or about to receive, immunosuppressive therapy, including corticosteroids and anti-TNF alpha inhibitors.

Exclusion Criteria

* Individuals who have not signed an informed consent
* Hemophiliacs or individuals who, on the advice of the enrolling physician, may otherwise be at increased risk of an adverse reaction to venipuncture or tuberculin skin test administration

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Oxford Immunotec

Principal Investigators

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Michael Gardam, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, University of Toronto

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

University Health Network