Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay

December 6, 2011 updated by: Won-Jung Koh, Samsung Medical Center
The present study was to evaluate the usefulness of a whole-blood interferon-r release assays (IGRAs) as diagnostic tool of the latent tuberculosis infection for healthcare workers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • doctors and nurses newly hired at Samsung Medical Center between February, 2008 and November, 2008.

Exclusion Criteria:

  • Non-applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: new healthcare workers
doctors and nurses who were newly hired in 2008 at the Samsung Medical Center
Other: 1-step tuberculin skin test (TST) and blood sampling
In only new healthcare workers, the 1-step TST and quantiFERON-TB Gold In-Tube test were performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea
Time Frame: QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of timw which from the start of the first test of very first participant to the end of second test of very last participant is 2 years.
The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test). Annual infection of tuberculosis infection was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test. The definitions for QFT-IT test conversion was based on the CDC definition (Baseline IFN-r < 0.35 IU/ml and follow-up IFN-r ≥ 0.35 IU/ml).
QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of timw which from the start of the first test of very first participant to the end of second test of very last participant is 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)
Time Frame: 3 months after LTBI treatment

The percentage of participants with negative conversion in follow-up QFT-IT test after LTBI treatment, out of those who had QFT-IT test conversion after one year of employment and agreed to undergo treatment for LTBI according to our recommendation

Participants with QFT-IT test conversion were recommended for LTBI therapy using 3 months of daily isoniazid and rifampicin, which was the regular treatment for LTBI in our institution.

The QFT-IT test was repeated after LTBI therapy. Negative conversion was defined as baseline IFN-r ≥ 0.35 and follow-up IFN-r < 0.35 IU/ml.
3 months after LTBI treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Won-Jung Koh, M.D., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 2, 2009

First Submitted That Met QC Criteria

November 3, 2009

First Posted (Estimate)

November 4, 2009

Study Record Updates

Last Update Posted (Estimate)

January 11, 2012

Last Update Submitted That Met QC Criteria

December 6, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-09-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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