NCT00449345

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
Last Updated

May 30, 2007

Status Verified

May 1, 2007

First QC Date

March 19, 2007

Last Update Submit

May 28, 2007

Conditions

Latent Tuberculosis Infection

Keywords

Latent tuberculosis infectionHealth care workersTuberculin skin testMantoux skin testInterferon gammaQuantiferonCost effectiveness

Interventions

Blood test for Quantiferon-GOLD assayPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health care worker undergoing screening for LTBI

You may not qualify if:

  • Previous tuberculosis or treatment for LTBI
  • Immunosuppressed due to drug treatment, HIV, organ transplant
  • Recent TB contacts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Tuberculosis service

Rehovot, Israel

RECRUITING

MeSH Terms

Conditions

Latent Tuberculosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsLatent Infection

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • David Shitrit, MD

    Maccabi Healthcare Services, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Shitrit, MD

CONTACT

+972 8 946 8617david_s@mac.org.il

Ben Fox, MRCP

CONTACT

+972 8 946 8617fox_b@mac.org.il

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 20, 2007

Study Start

May 1, 2007

Last Updated

May 30, 2007

Record last verified: 2007-05

Locations

IL(1)