Status:

COMPLETED

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

Lead Sponsor:

University Health Network, Toronto

Collaborating Sponsors:

Oxford Immunotec

Conditions:

Tuberculosis

Eligibility:

All Genders

18+ years

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...

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 rec...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 1 2005

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2005

Estimated Enrollment :

203 Patients enrolled

Trial Details

Trial ID

NCT00134342

Start Date

January 1 2005

End Date

April 1 2005

Last Update

December 23 2010

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Mount Sinai Hospital

Toronto, Ontario, Canada, M5G 1X5

2

University Health Network

Toronto, Ontario, Canada, M5G 2C4