Latent Tuberculosis Infection in Korean Health Care Workers

Latent Tuberculosis Clinical Trial

Official title:

Latent Tuberculosis Infection in Korean Health Care Workers Using Interferon Gamma Releasing Assay

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03010111
• Other study ID #: HYUMC_CM_001
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2016
• Last updated: January 3, 2017
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Hanyang University
• Contact: Dong Won Park, M.D., Ph.D.
• Email: portrayme[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators aim to study the prevalence of latent tuberculosis infection (LTBI) using whole-blood interferon-r release assays, and determine the risk factors of LTBI in Korean health care workers.

Description:

Further study details as provided by Hanyang University Hospital

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Health care workers in University affiliated hospital

• Adult aged 20-65

Exclusion Criteria:

• Active tuberculosis

• Subjects diagnosed with HIV infection, malignancy

• Subjects having immunosuppressive drug therapy

Study Design

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

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Intervention

Other:
• QFT-IT Test and other blood sampling
In all enrolled health care workers, QFT-IT Test and other blood sampling were performed.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of latent tuberculosis infection developed in Korean health care workers	The participants performed QuaniFERON-TB Gold In-Tube test (QFT-IT test) and blood sampling at enrollment. So, the length of time which from the start of the first test of very first participants to the end of test of very last participant is 3 months. The percentage of participants with LTBI in health care workers was evaluated.	Three months	No
Secondary	Annual incidence of latent tuberculosis infection in Korean health care workers	QFT-IT test was performed at enrollment and repeated at point of one year after enrollment. So, the length of time which from the start of the first test of very first participants to the end of the second test of very last participant is 12 to 15 months. The percentage of participants with positive conversion in follow-up QFT-IT test (second test) was evaluated in participants who had negative results in the first QFT-IT test. Annual infection of LTBI was evaluated with the conversion of QFT-IT test through annual check up of QFT-IT test.	1 year after first QFT-IT test (12-15 months)	No