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Latent Tuberculosis Infection in Korean Health Care Workers

Primary Purpose

Latent Tuberculosis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
QFT-IT Test and other blood sampling
Sponsored by
Hanyang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Latent Tuberculosis focused on measuring Latent Tuberculosis, Interferons, Tuberculosis, Healthcare

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hanyang University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

health care workers

Arm Description

health care workers including doctors, nurses, technicians and orderly who were hired in 2016 at the Hanyang University Hospital

Outcomes

Primary Outcome Measures

Percentage of latent tuberculosis infection developed in Korean health care workers
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.

Secondary Outcome Measures

Annual incidence of latent tuberculosis infection in Korean health care workers
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.

Full Information

First Posted
December 17, 2016
Last Updated
January 3, 2017
Sponsor
Hanyang University
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1. Study Identification

Unique Protocol Identification Number
NCT03010111
Brief Title
Latent Tuberculosis Infection in Korean Health Care Workers
Official Title
Latent Tuberculosis Infection in Korean Health Care Workers Using Interferon Gamma Releasing Assay
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Further study details as provided by Hanyang University Hospital

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis
Keywords
Latent Tuberculosis, Interferons, Tuberculosis, Healthcare

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
health care workers
Arm Type
Other
Arm Description
health care workers including doctors, nurses, technicians and orderly who were hired in 2016 at the Hanyang University Hospital
Intervention Type
Other
Intervention Name(s)
QFT-IT Test and other blood sampling
Intervention Description
In all enrolled health care workers, QFT-IT Test and other blood sampling were performed.
Primary Outcome Measure Information:
Title
Percentage of latent tuberculosis infection developed in Korean health care workers
Description
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.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Annual incidence of latent tuberculosis infection in Korean health care workers
Description
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.
Time Frame
1 year after first QFT-IT test (12-15 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dong Won Park, M.D., Ph.D.
Email
portrayme@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jang Won Shon, M.D., Ph.D.
Organizational Affiliation
Hanyang University Hospital, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hanyang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jang Won Shon, M.D., Ph.D.
Phone
82-2-2290-8351
Email
jwsohn@hanyang.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Latent Tuberculosis Infection in Korean Health Care Workers

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