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Completed

NCT Number: NCT00402402

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

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

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Key information

Conditions

Chronic Liver Disease Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Latent Infection Latent Tuberculosis Liver Transplantation Mycobacterium Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Univcersity Health Network

Toronto, Ontario, M5G 2N2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tuberculin skin test

Procedure

Quantiferon-TB Gold assay

Procedure

Primary outcomes

  1. Concordance between the Quantiferon-TB Gold assay and the tuberculin skin test

  2. Correlation of the test results to the patient's risk of latent TB infection

Secondary outcomes

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

  2. Frequency of anergy in this patient population

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Nov 22, 2006
Registry last updated
Apr 16, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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