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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01850043
Other study ID # KoreanTSTtrends
Secondary ID
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


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
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