Tuberculosis (TB) Screening for the Diagnosis of Latent TB in Immunocompromised Populations
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|ClinicalTrials.gov Identifier: NCT00134342|
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : December 23, 2010
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 or disease||Intervention/treatment||Phase|
|Tuberculosis||Other: T-SPOT TB ELISPOT test||Phase 3|
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.
|Study Type :||Observational|
|Actual Enrollment :||203 participants|
|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|
|Study Start Date :||January 2005|
|Primary Completion Date :||April 2005|
|Study Completion Date :||April 2005|
Other: T-SPOT TB ELISPOT test
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134342
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Michael Gardam, MD||University Health Network, University of Toronto|