The Epidemiology of TST Change in Korea

December 11, 2013 updated by: Sei Won Lee, Asan Medical Center

The Trend of Tuberculin Skin Test in Korea

TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC recommendation. Participants with chest radiograph showing active TB lesion are excluded from this study.

Study Overview

Status

Completed

Detailed Description

Enroll criteria

  • A term of whole military conscripts per year in one Reserve Force Battalion
  • Military conscripts gather from all around area in Korea randomly
  • Each participant undertake a chest X-ray (CXR) and blood tests including human immunodeficiency virus (HIV) at the start of initiatory training.

Exclusion Criteria

  • Chest X-ray suggesting active TB
  • HIV positive in serology

Design

  • After giving informed consent, all participants receive one-step TST following standard procedures.
  • The largest transverse diameter of induration is measured 48-72hr after injection.
  • The investigator and these trained nurses were blinded to the status of their demographic characteristics.

Study Type

Observational

Enrollment (Actual)

5552

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

    • Chungcheongbuk-Do
      • Osong, Chungcheongbuk-Do, Korea, Republic of, 396-954
        • The Korean Institute of Tuberculosis

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

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

A term of whole military conscripts per year

Description

Inclusion Criteria:

  • Military Conscripts age 18-29 years old

Exclusion Criteria:

  • Chest X-ray suggests active TB
  • Positive HIV in serology

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

Cohorts and Interventions

Group / Cohort
Military Conscripts
A term of whole military conscripts per year in one Reserve Force Battalion. Military conscripts gather from all around area in Korea randomly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TST positivity TST rate
Time Frame: Two days after tuberculin injection
Investigators measure induration size of tuberculin skin test 48 after tuberculin injection.
Two days after tuberculin injection

Secondary Outcome Measures

Outcome Measure
Time Frame
BCG scar rates
Time Frame: The day of tuberculin injection
The day of tuberculin injection

Collaborators and Investigators

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

Investigators

  • Principal Investigator: HeeJin Kim, MD, The Korean Institute of Tuberculosis

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

May 1, 2005

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

December 12, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

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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