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NCT00449345 Clinical Trial

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

Latent Tuberculosis Infection Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00449345
Other study ID # 2006055
Secondary ID
Status Recruiting
Phase N/A
First received March 19, 2007
Last updated May 28, 2007
Start date May 2007

Study information
Verified date May 2007
Source Assuta Hospital Systems
Contact David Shitrit, MD
Phone +972 8 946 8617
Email david_s@mac.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood test for Quantiferon-GOLD assay

Locations
Country Name City State
Israel Community Tuberculosis service Rehovot

Sponsors (2)
Lead Sponsor Collaborator
Assuta Hospital Systems Maccabi

Country where clinical trial is conducted

Israel, 

See also
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