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
  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:


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:
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 April 23, 2014