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

NCT00402402 | Completed Phase 4

• 1 other identifier: 06-0648-AE
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Liver Disease; Liver Transplantation; Tuberculosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Factors associated with discordance between the TST and the QFT-G test

• Frequency of anergy in this patient population

Interventions

Tuberculin skin test PROCEDURE

Quantiferon-TB Gold assay PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic liver disease on the waiting list or being wait listed for liver transplantation

You may not qualify if:

• Unable to provide informed consent
• Previous history of immediate hypersensitivity to TST
• Previous severe local ulceration with TST
• Suspected active TB

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Univcersity Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (3)

• 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. doi: 10.1097/00007890-200211270-00006.

  PMID: 12451235 BACKGROUND

• 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. doi: 10.1164/rccm.200502-196OC. Epub 2005 Jun 16.

  PMID: 15961696 BACKGROUND

• 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. doi: 10.1001/jama.293.22.2746.

  PMID: 15941804 BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Interventions

Tuberculin

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Officials

• Deepali Kumar, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 22, 2006
• Study Start: October 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: April 16, 2008

Record last verified: 2006-11

Locations

CA (1)