Comparison of the Quantiferon®-TB GOLD (in Tube) Assay With Tuberculin Skin Testing for Detecting Latent Tuberculosis Infection in Patients With Chronic Liver Disease Being Evaluated for or Awaiting Liver Transplantation

NCT00424684 | Withdrawn

• 1 other identifier: IRB#0611163
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Tuberculosis (TB) is an important cause of morbidity and mortality in organ transplant recipients. Management of tuberculosis in this setting is challenging due to the complexity of diagnosis and the potential toxicity of anti-TB therapy, especially in liver transplant candidates and 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 (false-positive results due to interaction with BCG vaccine and other mycobacterial infections), 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 detects the release of interferon-gamma (IFN-γ) by sensitized white cells after incubation of whole blood with TB antigens. 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. This study advances research on the prevention of a serious bacterial infection that can have devastating consequences in the post-transplant setting. The new diagnostic strategy may more accurately determine the presence of LTBI, thereby allowing appropriate therapy.

Conditions

Chronic Liver Disease; TB

Keywords

TB; Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• To assess the concordance between the QFT-G IT assay and the TST in patients with end stage liver disease awaiting liver transplantation and to relate the test results to the patient's risk of latent TB infection.

Secondary Outcomes (3)

• To assess the factors that are associated with discordance between the TST and the QFT-G test

• To assess for laboratory parameters that may influence the QFT-G IT assay, such as lymphocyte count and liver function tests.

• To assess the frequency of anergy in this patient population.

Interventions

collection of blood sample PROCEDURE

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18
• Chronic liver disease on the waiting list or being wait listed for liver transplantation
• Undergoing a PPD test as part of their clinical care

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 of Pittsburgh: lead
• Cellestis: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Fernanda Silveira, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• David L Paterson, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 19, 2007
• Study Start: January 1, 2007
• Last Updated: May 7, 2020

Record last verified: 2015-12

Locations

US (1)