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

NCT ID: NCT00449345

Last Updated: 2007-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Latent Tuberculosis Infection

Keywords

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Latent tuberculosis infection Health care workers Tuberculin skin test Mantoux skin test Interferon gamma Quantiferon Cost effectiveness

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Blood test for Quantiferon-GOLD assay

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maccabi Healthcare Services, Israel

OTHER

Sponsor Role collaborator

Assuta Hospital Systems

OTHER

Sponsor Role lead

Principal Investigators

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David Shitrit, MD

Role: PRINCIPAL_INVESTIGATOR

Maccabi Healthcare Services, Israel

Locations

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Community Tuberculosis service

Rehovot, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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David Shitrit, MD

Role: CONTACT

Phone: +972 8 946 8617

Email: [email protected]

Ben Fox, MRCP

Role: CONTACT

Phone: +972 8 946 8617

Email: [email protected]

Other Identifiers

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2006055

Identifier Type: -

Identifier Source: org_study_id