Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
Primary Purpose
Latent Tuberculosis Infection
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
1-step tuberculin skin test (TST) and blood sampling
Sponsored by
About this trial
This is an interventional screening trial for Latent Tuberculosis Infection focused on measuring Interferon-gamma release assay
Eligibility Criteria
Inclusion Criteria:
- doctors and nurses newly hired at Samsung Medical Center between February, 2008 and November, 2008.
Exclusion Criteria:
- Non-applicable
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
new healthcare workers
Arm Description
doctors and nurses who were newly hired in 2008 at the Samsung Medical Center
Outcomes
Primary Outcome Measures
Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea
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)
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.
Full Information
NCT ID
NCT01007396
First Posted
November 2, 2009
Last Updated
December 6, 2011
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01007396
Brief Title
Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
Official Title
Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
Study Type
Interventional
2. Study Status
Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Latent Tuberculosis Infection
Keywords
Interferon-gamma release assay
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
322 (Actual)
8. Arms, Groups, and Interventions
Arm Title
new healthcare workers
Arm Type
Other
Arm Description
doctors and nurses who were newly hired in 2008 at the Samsung Medical Center
Intervention Type
Other
Intervention Name(s)
1-step tuberculin skin test (TST) and blood sampling
Intervention Description
In only new healthcare workers, the 1-step TST and quantiFERON-TB Gold In-Tube test were performed.
Primary Outcome Measure Information:
Title
Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea
Description
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).
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.
Secondary Outcome Measure Information:
Title
Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)
Description
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.
Time Frame
3 months after LTBI treatment
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
doctors and nurses newly hired at Samsung Medical Center between February, 2008 and November, 2008.
Exclusion Criteria:
Non-applicable
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won-Jung Koh, M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
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