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

Latent Tuberculosis Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007396
• Other study ID #: 2007-09-019
• Status: Completed
• Phase: N/A
• First received: November 2, 2009
• Last updated: December 6, 2011
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: December 2011
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-applicable

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Infection
• Latent Tuberculosis
• Latent Tuberculosis Infection
• Tuberculosis

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	3 months after LTBI treatment	No