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

NCT00134342 | Completed

• 1 other identifier: 04-0702-AE
• Study Type: observational
• Target: 203
• Locations: 1 country
• Sites: 2

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.

Conditions

Tuberculosis

Keywords

tuberculosis; tuberculin test; immunologic tests; Latent tuberculosis; end stage renal disease; solid organ transplantation; bone marrow transplantation; rheumatologic disease

Interventions

T-SPOT TB ELISPOT test OTHER

ELISPOT test for detecting T cell responses to tuberculosis antigens.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with endstage renal disease

You may qualify if:

• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Oxford Immunotec: collaborator

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis; Kidney Failure, Chronic; Collagen Diseases

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Michael Gardam, MD

  University Health Network, University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 22, 2005
• First Posted: August 24, 2005
• Study Start: January 1, 2005
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: December 23, 2010

Record last verified: 2005-07

Locations

CA (2)