Tuberculosis Clinical Trial
Official title:
Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing for Detecting Latent Mycobacterium Tuberculosis Infection in Patients With Chronic Liver Disease Awaiting Liver Transplantation
Verified date | November 2006 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
The purpose of the study is to estimate the usefulness of the QuantiFERON®-TB Gold test for the diagnosis of latent tuberculosis infection in liver transplant candidates by correlating the test results with risk factors for LTBI
Status | Completed |
Enrollment | 300 |
Est. completion date | July 2007 |
Est. primary completion date | July 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Chronic liver disease on the waiting list or being wait listed for liver transplantation Exclusion Criteria: - Unable to provide informed consent - Previous history of immediate hypersensitivity to TST - Previous severe local ulceration with TST - Suspected active TB |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Canada | Univcersity Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Benito N, Sued O, Moreno A, Horcajada JP, González J, Navasa M, Rimola A. Diagnosis and treatment of latent tuberculosis infection in liver transplant recipients in an endemic area. Transplantation. 2002 Nov 27;74(10):1381-6. — View Citation
Ferrara G, Losi M, Meacci M, Meccugni B, Piro R, Roversi P, Bergamini BM, D'Amico R, Marchegiano P, Rumpianesi F, Fabbri LM, Richeldi L. Routine hospital use of a new commercial whole blood interferon-gamma assay for the diagnosis of tuberculosis infection. Am J Respir Crit Care Med. 2005 Sep 1;172(5):631-5. Epub 2005 Jun 16. — View Citation
Pai M, Gokhale K, Joshi R, Dogra S, Kalantri S, Mendiratta DK, Narang P, Daley CL, Granich RM, Mazurek GH, Reingold AL, Riley LW, Colford JM Jr. Mycobacterium tuberculosis infection in health care workers in rural India: comparison of a whole-blood interferon gamma assay with tuberculin skin testing. JAMA. 2005 Jun 8;293(22):2746-55. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concordance between the Quantiferon-TB Gold assay and the tuberculin skin test | |||
Primary | Correlation of the test results to the patient's risk of latent TB infection | |||
Secondary | Factors associated with discordance between the TST and the QFT-G test | |||
Secondary | Frequency of anergy in this patient population |
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