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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01007396
Recruitment Status : Completed
First Posted : November 4, 2009
Results First Posted : January 11, 2012
Last Update Posted : January 11, 2012
Information provided by (Responsible Party):
Won-Jung Koh, Samsung Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Latent Tuberculosis Infection Other: 1-step tuberculin skin test (TST) and blood sampling Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 322 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
Study Start Date : January 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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. ]
    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 :
  1. 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 ]

    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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Non-applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01007396

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

Responsible Party: Won-Jung Koh, MD, PhD, Associated professor, school of medicine, sungkyunkwan university, Samsung Medical Center Identifier: NCT01007396     History of Changes
Other Study ID Numbers: 2007-09-019
First Posted: November 4, 2009    Key Record Dates
Results First Posted: January 11, 2012
Last Update Posted: January 11, 2012
Last Verified: December 2011

Keywords provided by Won-Jung Koh, Samsung Medical Center:
Interferon-gamma release assay

Additional relevant MeSH terms:
Communicable Diseases
Latent Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents