Conversion Rate of (TST) Tuberculin Skin Test and Quantif... | NCT01376843

Studies
Conversion Rate of (TST) Tuberculin Skin Test and Quantiferon-TB Gold In Tube Assay in Health Care Workers

NCT01376843

Sponsor

Yonsei University

Status

Completed

Last Update Posted

Mar 6, 2013Estimated

Enrollment

53Actual

Phase

Not provided

Conditions

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

Mar 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

Jun 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Jun 16, 2011

First Submission Date that Met QC Criteria

Jun 17, 2011

First Posted Date

Jun 20, 2011Estimated

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

Mar 4, 2013

Last Update Posted Date

Mar 6, 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

The purpose of this study is to access conversion rate of TST (Tuberculin skin test) and Quantiferon-TB Gold In tube assay in health care workers.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Health care workers		health care workers who performed TST or Quantiferon-TB Gold In tube assay before

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
conversion rate of latent tuberculosis infection in hospital workers		3months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 20-75, men and women
participant who was enrolled in the study of latent tuberculosis in health care worker (IRB No.4-2009-0187)
high risk or low risk health care worker who was performed TST or Quantiferon-TB Gold In tube assay before

Exclusion Criteria:

age < 20
person who don't agree with enrollment
illiterate
person who is diagnosed as active tuberculosis now
person who has history of hypersensitivity on PPD (tuberculin purified protein derivative)
pregnant woman
person who is treated as active tuberculosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

health care workers who performed TST or Quantiferon-TB Gold In tube assay before

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Hospital		Seoul		120-752	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7990907	Background	Menzies D, Fanning A, Yuan L, Fitzgerald M. Tuberculosis among health care workers. N Engl J Med. 1995 Jan 12;332(2):92-8. doi: 10.1056/NEJM199501123320206. No abstract available.
16333934	Background	Jiamjarasrangsi W, Hirunsuthikul N, Kamolratanakul P. Tuberculosis among health care workers at King Chulalongkorn Memorial Hospital, 1988-2002. Int J Tuberc Lung Dis. 2005 Nov;9(11):1253-8.

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