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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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
2
University Health Network
Toronto, Ontario, Canada, M5G 2C4