Tuberculosis (TB) Screening for the Diagnosis of Latent TB in Immunocompromised Populations - Full Text View

Sponsors and Collaborators:	University Health Network, Toronto Oxford Immunotec, Oxford, UK
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00134342

Purpose

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

MedlinePlus related topics: Tuberculosis

Drug Information available for: Tuberculin Purified Protein Derivative

U.S. FDA Resources

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

Further study details as provided by University Health Network, Toronto:

Estimated Enrollment:	400
Study Start Date:	January 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134342

Contacts

Contact: Michael Gardam, MD

416-340-4800 ext 8422

michael.gardam@uhn.on.ca

Locations

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

Sponsors and Collaborators

University Health Network, Toronto

Oxford Immunotec, Oxford, UK

Investigators

Principal Investigator:

Michael Gardam, MD

University Health Network, University of Toronto

More Information

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

Keywords provided by University Health Network, Toronto:

tuberculosis
tuberculin test
immunologic tests
Latent tuberculosis

end stage renal disease
solid organ transplantation
bone marrow transplantation
rheumatologic disease

Study placed in the following topic categories:

Bacterial Infections
Gram-Positive Bacterial Infections
Kidney Failure, Chronic

Mycobacterium Infections
Tuberculosis
Kidney Diseases

Additional relevant MeSH terms:

Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009