|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00134342 |
|
Date of registration:
|
22/08/2005 |
|
Primary sponsor: |
|
|
Public title:
|
Tuberculosis (TB) Screening for the Diagnosis of Latent TB in Immunocompromised Populations
|
|
Scientific title:
|
A Comparison of Traditional Tuberculosis Screening Methods With the T-SPOT TB Test for the Diagnosis of Latent Tuberculosis Infection in Immunocompromised Populations |
|
Date of first enrolment:
|
January 2005 |
|
Target sample size:
|
203 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00134342 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Michael Gardam, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Health Network, University of Toronto |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Tuberculosis
|
|
Intervention(s)
|
|
Other: T-SPOT TB ELISPOT test
|
|
Secondary ID(s)
|
|
04-0702-AE
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|