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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03010111
Other study ID # HYUMC_CM_001
Secondary ID
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


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
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