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Sponsors and Collaborators: |
University Health Network, Toronto Oxford Immunotec, Oxford, UK |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00134342 |
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.
Condition | Intervention | Phase |
---|---|---|
Tuberculosis |
Device: T-SPOT TB ELISPOT test |
Phase III |
Study Type: | Observational |
Study Design: | Screening, Longitudinal, Defined Population, Prospective Study |
Official Title: | A Comparison of Traditional Tuberculosis Screening Methods With the T-SPOT TB Test for the Diagnosis of Latent Tuberculosis Infection in Immunocompromised Populations |
Estimated Enrollment: | 400 |
Study Start Date: | January 2005 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Inclusion criteria for the study are broad.
Patients belonging to the four following groups will be considered eligible for tuberculosis screening and inclusion in the T-SPOT ELISPOT study:
Exclusion Criteria:
Contact: Michael Gardam, MD | 416-340-4800 ext 8422 | michael.gardam@uhn.on.ca |
Canada, Ontario | |
University Health Network | Recruiting |
Toronto, Ontario, Canada, M5G 2C4 | |
Contact: Michael Gardam, MD 416-340-4800 ext 8422 michael.gardam@uhn.on.ca | |
Principal Investigator: Michael Gardam, MD | |
Mount Sinai Hospital | Not yet recruiting |
Toronto, Ontario, Canada, M5G 1X5 | |
Contact: Michael Gardam, MD 416-349-4800 ext 8422 michael.gardam@uhn.on.ca | |
Principal Investigator: Michael Gardam, MD |
Principal Investigator: | Michael Gardam, MD | University Health Network, University of Toronto |
Study ID Numbers: | 04-0702-AE |
Study First Received: | August 22, 2005 |
Last Updated: | February 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00134342 |
Health Authority: | Canada: Health Canada |
tuberculosis tuberculin test immunologic tests Latent tuberculosis |
end stage renal disease solid organ transplantation bone marrow transplantation rheumatologic disease |
Bacterial Infections Gram-Positive Bacterial Infections Kidney Failure, Chronic |
Mycobacterium Infections Tuberculosis Kidney Diseases |
Actinomycetales Infections |