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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402402
• Other study ID #: 06-0648-AE
• Status: Completed
• Phase: Phase 4
• First received: November 21, 2006
• Last updated: April 15, 2008
• Start date: October 2006
• Est. completion date: July 2007

Study information

• Verified date: November 2006
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases
• Liver Transplantation
• Tuberculosis

Intervention

Procedure:
• Tuberculin skin test

• Quantiferon-TB Gold assay

Locations

Country	Name	City	State
Canada	Univcersity Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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

Outcome

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