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

This study is currently recruiting participants.

Verified by Assuta Hospital Systems, May 2007

First Received: March 19, 2007 Last Updated: May 28, 2007 History of Changes

Sponsor:	Assuta Hospital Systems
Collaborator:	Maccabi
Information provided by:	Assuta Hospital Systems
ClinicalTrials.gov Identifier:	NCT00449345

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:	Screening, Longitudinal, Defined Population, Prospective Study

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Further study details as provided by Assuta Hospital Systems:

Estimated Enrollment:	150
Study Start Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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 Health Services

More Information

No publications provided

Study ID Numbers:	2006055
Study First Received:	March 19, 2007
Last Updated:	May 28, 2007
ClinicalTrials.gov Identifier:	NCT00449345 History of Changes
Health Authority:	Israel: Ministry of Health

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:

Bacterial Infections
Communicable Diseases
Gram-Positive Bacterial Infections
Mycobacterium Infections

Tuberculosis
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on February 08, 2010