Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
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|ClinicalTrials.gov Identifier: NCT01007396|
Recruitment Status : Completed
First Posted : November 4, 2009
Results First Posted : January 11, 2012
Last Update Posted : January 11, 2012
|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)|
|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|
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.
- 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).
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01007396
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Won-Jung Koh, M.D.||Samsung Medical Center|