Comparison of Quantiferon-TB Gold Assay With Tuberculin Skin Testing in Patients With Chronic Liver Disease - Full Text View

Sponsor:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00402402

Purpose

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

Condition	Intervention	Phase
Chronic Liver Disease Liver Transplantation Tuberculosis	Procedure: Tuberculin skin test Procedure: Quantiferon-TB Gold assay	Phase IV

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases Liver Transplantation Tuberculosis

Drug Information available for: Tuberculin Purified Protein Derivative

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

Concordance between the Quantiferon-TB Gold assay and the tuberculin skin test
Correlation of the test results to the patient's risk of latent TB infection

Secondary Outcome Measures:

Factors associated with discordance between the TST and the QFT-G test
Frequency of anergy in this patient population

Estimated Enrollment:	300
Study Start Date:	October 2006
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Detailed Description:

Tuberculosis (TB) is an important cause of morbidity and mortality in organ transplant recipients. Although the tuberculin skin test (TST) is recommended for screening of latent tuberculosis infection (LTBI) in all candidates for liver transplantation, the performance of the TST in this setting is less than optimal, due to a lack of specificity and a lack of sensitivity in a population that is relatively immunocompromised. Recently, a new test named QuantiFERON-TB Gold (QFT-G) has been approved for the diagnosis of LTBI. QFT-G is expected to be more specific than TST. However, there are no studies defining the performance of QFT-G in a population of patients on a waiting list for liver transplantation. We plan to estimate the usefulness of the QFT-G test for the diagnosis of LTBI in a cohort of patients with end-stage liver disease. We hypothesize that the QFT-G test will correlate better with the risk of LTBI.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00402402

Locations

Canada, Ontario
Univcersity Health Network
Toronto, Ontario, Canada, M5G 2N2

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Deepali Kumar, MD

University Health Network, Toronto

More Information

Publications:

Benito N, Sued O, Moreno A, Horcajada JP, Gonzalez 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.

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.

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.

Study ID Numbers:	06-0648-AE
Study First Received:	November 21, 2006
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00402402 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

Tuberculin skin test
Quantiferon-TB Gold assay
Chronic liver disease
Liver transplantation
Latent tuberculosis infection

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Liver Diseases
Digestive System Diseases

Mycobacterium Infections
Tuberculosis
Actinomycetales Infections

ClinicalTrials.gov processed this record on February 09, 2010