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