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

Not Applicable

Completed

• Conditions: Latent Tuberculosis Infection
• Interventions: Other: 1-step tuberculin skin test (TST) and blood sampling

• Registration Number: NCT01007396
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-11-03
• Study First Posted: 2009-11-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-05-17
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-06
• Last Update Submitted: 2011-12-06
• Results First Posted: 2012-01-11
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 322

Inclusion Criteria

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

Exclusion Criteria

• Non-applicable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
new healthcare workers	1-step tuberculin skin test (TST) and blood sampling	doctors and nurses who were newly hired in 2008 at the Samsung Medical Center

Primary Outcome Measures

Name	Time	Method
Annual Incidence of Tuberculosis Infection Among Newly Employed Doctors and Nurses in Korea	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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of