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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yonsei University

ClinicalTrials.gov Identifier:

NCT01376843

First received: June 16, 2011

Last updated: March 4, 2013

Last verified: March 2013

History of Changes

Purpose

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.

Condition
Tuberculosis

Study Type:	Observational
Study Design:	Observational Model: Case-Crossover Time Perspective: Prospective
Official Title:	Conversion Rate of TST and Quantiferon-TB Gold In Tube Assay in Health Care Workers

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:

conversion rate of latent tuberculosis infection in hospital workers [ Time Frame: 3months ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

whole blood for perfoming Quantiferon-TB Gold in tube assay

Enrollment:	53
Study Start Date:	June 2011
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Health care workers health care workers who performed TST or Quantiferon-TB Gold In tube assay before

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01376843

Locations

Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 120-752

Sponsors and Collaborators

Yonsei University

More Information

Publications:

Menzies D, Fanning A, Yuan L, Fitzgerald M. Tuberculosis among health care workers. N Engl J Med. 1995 Jan 12;332(2):92-8. Review. No abstract available.

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.

Schwartzman K, Loo V, Pasztor J, Menzies D. Tuberculosis infection among health care workers in Montreal. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):1006-12.

Krüüner A, Danilovitsh M, Pehme L, Laisaar T, Hoffner SE, Katila ML. Tuberculosis as an occupational hazard for health care workers in Estonia. Int J Tuberc Lung Dis. 2001 Feb;5(2):170-6.

Responsible Party:	Yonsei University
ClinicalTrials.gov Identifier:	NCT01376843 History of Changes
Other Study ID Numbers:	4-2011-0161
Study First Received:	June 16, 2011
Last Updated:	March 4, 2013
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:

latent tuberculosis in health care workers

Additional relevant MeSH terms:

Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013

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