The Epidemiology of TST Change in Korea | NCT01850043

Studies
The Epidemiology of TST Change in Korea

NCT01850043

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Dec 12, 2013Estimated

Enrollment

5,552Actual

Phase

Not provided

Conditions

Tuberculosis
Latent Tuberculosis

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

May 2, 2013

First Submission Date that Met QC Criteria

May 7, 2013

First Posted Date

May 9, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2013

Last Update Posted Date

Dec 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,552Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
BCG scar rates		The day of tuberculin injection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Military Conscripts age 18-29 years old

Exclusion Criteria:

Chest X-ray suggests active TB
Positive HIV in serology

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

29 Years

Standard Ages

Adult

Study Population

A term of whole military conscripts per year

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
HeeJin Kim, MD	The Korean Institute of Tuberculosis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Korean Institute of Tuberculosis		Osong	North Chungcheong	396-954	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis
D055985	Latent Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided