The Epidemiology of TST Change in Korea

Tuberculosis Clinical Trial

Official title:

The Trend of Tuberculin Skin Test in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850043
• Other study ID #: KoreanTSTtrends
• Status: Completed
• Phase: N/A
• First received: May 2, 2013
• Last updated: December 11, 2013
• Start date: May 2005
• Est. completion date: May 2012

Study information

• Verified date: December 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5552
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

Inclusion Criteria:

• Military Conscripts age 18-29 years old

Exclusion Criteria:

• Chest X-ray suggests active TB

• Positive HIV in serology

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Locations

Country	Name	City	State
Korea, Republic of	The Korean Institute of Tuberculosis	Osong	Chungcheongbuk-Do

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TST positivity TST rate	Investigators measure induration size of tuberculin skin test 48 after tuberculin injection.	Two days after tuberculin injection	No
Secondary	BCG scar rates		The day of tuberculin injection	No