Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
1 other identifier
interventional
322
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 2, 2009
CompletedFirst Posted
Study publicly available on registry
November 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedResults Posted
Study results publicly available
January 11, 2012
CompletedJanuary 11, 2012
December 1, 2011
1.9 years
November 2, 2009
May 17, 2010
December 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
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 Outcomes (1)
Negative Conversion Rate in Follow-up QuantiFERON-TB Gold In-Tube Test (QFT-IT Test) After Treatment of Latent Tuberculosis Infection (LTBI)
3 months after LTBI treatment
Study Arms (1)
new healthcare workers
OTHERdoctors and nurses who were newly hired in 2008 at the Samsung Medical Center
Interventions
In only new healthcare workers, the 1-step TST and quantiFERON-TB Gold In-Tube test were performed.
Eligibility Criteria
You may qualify if:
- doctors and nurses newly hired at Samsung Medical Center between February, 2008 and November, 2008.
You may not qualify if:
- Non-applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Won-Jung Koh
- Organization
- Samsung Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Won-Jung Koh, M.D.
Samsung Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Associated professor, school of medicine, sungkyunkwan university
Study Record Dates
First Submitted
November 2, 2009
First Posted
November 4, 2009
Study Start
January 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
January 11, 2012
Results First Posted
January 11, 2012
Record last verified: 2011-12