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Screening for Latent Tuberculosis in Healthcare Workers With Quantiferon-Gold Assay: A Cost-Effectiveness Analysis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2007 by Assuta Hospital Systems.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00449345
First Posted: March 20, 2007
Last Update Posted: May 30, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Maccabi
Information provided by:
Assuta Hospital Systems
  Purpose

The ministry of health in Israel requires all health-care workers to undergo screening for latent Tuberculosis infection (LTBI) prior to starting work. This is based on the Mantoux skin test, which is notoriously unreliable.

In recent years, more specific and sensitive tests based on interferon-gamma secretion to TB antigens have come to market, and most current evidence shows that many mantoux positive persons do not have LTBI. Quantiferon-GOLD is one of these assays.

In this prospective study, we will draw blood for the Quantiferon-GOLD assay in parallel to conventional testing, and perform a cost-effectiveness analysis of the cost of the investigation and treatment of LTBI in health-care workers.

We hypothesize that in spite of the cost of screening healthcare workers with Quantiferon-GOLD tests, the reduction in need for LTBI treatment and associated costs will render the test cost-effective.


Condition Intervention
Latent Tuberculosis Infection Procedure: Blood test for Quantiferon-GOLD assay

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Assuta Hospital Systems:

Estimated Enrollment: 150
Study Start Date: May 2007
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Health care worker undergoing screening for LTBI

Exclusion Criteria:

  • Previous tuberculosis or treatment for LTBI
  • Immunosuppressed due to drug treatment, HIV, organ transplant
  • Recent TB contacts
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449345


Contacts
Contact: David Shitrit, MD +972 8 946 8617 david_s@mac.org.il
Contact: Ben Fox, MRCP +972 8 946 8617 fox_b@mac.org.il

Locations
Israel
Community Tuberculosis service Recruiting
Rehovot, Israel
Sponsors and Collaborators
Assuta Hospital Systems
Maccabi
Investigators
Principal Investigator: David Shitrit, MD Maccabi Healthcare Services, Israel
  More Information

ClinicalTrials.gov Identifier: NCT00449345     History of Changes
Other Study ID Numbers: 2006055
First Submitted: March 19, 2007
First Posted: March 20, 2007
Last Update Posted: May 30, 2007
Last Verified: May 2007

Keywords provided by Assuta Hospital Systems:
Latent tuberculosis infection
Health care workers
Tuberculin skin test
Mantoux skin test
Interferon gamma
Quantiferon
Cost effectiveness

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections