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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on October 29, 2014