Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Won-Jung Koh, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01007396
First received: November 2, 2009
Last updated: December 6, 2011
Last verified: December 2011
  Purpose

The present study was to evaluate the usefulness of a whole-blood interferon-r release assays (IGRAs) as diagnostic tool of the latent tuberculosis infection for healthcare workers.


Condition Intervention
Latent Tuberculosis Infection
Other: 1-step tuberculin skin test (TST) and blood sampling

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea [ Time Frame: QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of timw which from the start of the first test of very first participant to the end of second test of very last participant is 2 years. ] [ Designated as safety issue: No ]
    The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test). Annual infection of tuberculosis infection was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test. The definitions for QFT-IT test conversion was based on the CDC definition (Baseline IFN-r < 0.35 IU/ml and follow-up IFN-r ≥ 0.35 IU/ml).


Secondary Outcome Measures:
  • Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI) [ Time Frame: 3 months after LTBI treatment ] [ Designated as safety issue: No ]

    The percentage of participants with negative conversion in follow-up QFT-IT test after LTBI treatment, out of those who had QFT-IT test conversion after one year of employment and agreed to undergo treatment for LTBI according to our recommendation

    Participants with QFT-IT test conversion were recommended for LTBI therapy using 3 months of daily isoniazid and rifampicin, which was the regular treatment for LTBI in our institution.

    The QFT-IT test was repeated after LTBI therapy. Negative conversion was defined as baseline IFN-r ≥ 0.35 and follow-up IFN-r < 0.35 IU/ml.



Enrollment: 322
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
new healthcare workers
doctors and nurses who were newly hired in 2008 at the Samsung Medical Center
Other: 1-step tuberculin skin test (TST) and blood sampling
In only new healthcare workers, the 1-step TST and quantiFERON-TB Gold In-Tube test were performed.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • doctors and nurses newly hired at Samsung Medical Center between February, 2008 and November, 2008.

Exclusion Criteria:

  • Non-applicable
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01007396

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Won-Jung Koh, M.D. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Won-Jung Koh, MD, PhD, Associated professor, school of medicine, sungkyunkwan university, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01007396     History of Changes
Other Study ID Numbers: 2007-09-019
Study First Received: November 2, 2009
Results First Received: May 17, 2010
Last Updated: December 6, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Interferon-gamma release assay

Additional relevant MeSH terms:
Infection
Communicable Diseases
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Interferons
Interferon-gamma
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 22, 2014