Latent Tuberculosis Infection in Korean Health Care Workers

January 3, 2017 updated by: Dong Won Park, Hanyang University

Latent Tuberculosis Infection in Korean Health Care Workers Using Interferon Gamma Releasing Assay

The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean health care workers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Further study details as provided by Hanyang University Hospital

Study Type

Interventional

Enrollment (Anticipated)

240

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 Contact

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Health care workers in University affiliated hospital
  • Adult aged 20-65

Exclusion Criteria:

  • Active tuberculosis
  • Subjects diagnosed with HIV infection, malignancy
  • Subjects having immunosuppressive drug therapy

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: health care workers
health care workers including doctors, nurses, technicians and orderly who were hired in 2016 at the Hanyang University Hospital
Other: QFT-IT Test and other blood sampling
In all enrolled health care workers, QFT-IT Test and other blood sampling were performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of latent tuberculosis infection developed in Korean health care workers
Time Frame: Three months
The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test) and blood sampling at enrollment. So, the length of time which from the start of the first test of very first participants to the end of test of very last participant is 3 months. The percentage of participants with LTBI in health care workers was evaluated.
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annual incidence of latent tuberculosis infection in Korean health care workers
Time Frame: 1 year after first QFT-IT test (12-15 months)
QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of time which from the start of the first test of very first participants to the end of the second test of very last participant is 12 to 15 months. The percentage of participants with positive conversion in follow-up QFT-IT test (second test) was evaluated in participants who had negative results in the first QFT-IT test. Annual infection of LTBI was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test.
1 year after first QFT-IT test (12-15 months)

Collaborators and Investigators

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

Sponsor

Hanyang University

Investigators

  • Principal Investigator: Jang Won Shon, M.D., Ph.D., Hanyang University Hospital, Seoul, Korea

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

December 1, 2016

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

December 17, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Estimate)

January 4, 2017

Last Update Submitted That Met QC Criteria

January 3, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYUMC_CM_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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Locations

3
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