Trial record 2 of 6 for:    oxford immunotec

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00134342
Recruitment Status : Completed
First Posted : August 24, 2005
Last Update Posted : December 23, 2010
Oxford Immunotec
Information provided by:
University Health Network, Toronto

Brief Summary:

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
Tuberculosis Other: T-SPOT TB ELISPOT test

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes Tuberculosis

Intervention Details:
  • Other: T-SPOT TB ELISPOT test
    ELISPOT test for detecting T cell responses to tuberculosis antigens.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with endstage renal disease

Inclusion Criteria:

Inclusion criteria for the study are broad.

  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00134342

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Oxford Immunotec
Principal Investigator: Michael Gardam, MD University Health Network, University of Toronto

Responsible Party: Nial Ferguson, Oxford Immunotec Identifier: NCT00134342     History of Changes
Other Study ID Numbers: 04-0702-AE
First Posted: August 24, 2005    Key Record Dates
Last Update Posted: December 23, 2010
Last Verified: July 2005

Keywords provided by University Health Network, Toronto:
tuberculin test
immunologic tests
Latent tuberculosis
end stage renal disease
solid organ transplantation
bone marrow transplantation
rheumatologic disease

Additional relevant MeSH terms:
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections