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

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ClinicalTrials.gov Identifier: NCT00449345
Recruitment Status : Unknown
Verified May 2007 by Assuta Hospital Systems.
Recruitment status was:  Recruiting
First Posted : March 20, 2007
Last Update Posted : May 30, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Latent Tuberculosis Infection Procedure: Blood test for Quantiferon-GOLD assay

Study Design

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

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 Posted: March 20, 2007    Key Record Dates
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