Diagnosis of Tuberculosis Infection in Health Care Workers Using Ex-vivo Interferon-gamma Assay
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 322
- Locations
- 1
- Primary Endpoint
- Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Sex
- 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
Arms & Interventions
new healthcare workers
doctors and nurses who were newly hired in 2008 at the Samsung Medical Center
Intervention: 1-step tuberculin skin test (TST) and blood sampling (Other)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
Investigators
Won-Jung Koh
MD, PhD, Associated professor, school of medicine, sungkyunkwan university
Samsung Medical Center