Latent Tuberculosis Infection in Korean Health Care Workers

Not Applicable

• Conditions: Latent Tuberculosis
• Interventions: Other: QFT-IT Test and other blood sampling

• Registration Number: NCT03010111
• Lead Sponsor: Hanyang University

Brief 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.

Detailed Description

Further study details as provided by Hanyang University Hospital

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-17
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-03
• Last Update Submitted: 2017-01-03
• Study First Posted: 2017-01-04
• Last Update Posted: 2017-01-04
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
health care workers	QFT-IT Test and other blood sampling	health care workers including doctors, nurses, technicians and orderly who were hired in 2016 at the Hanyang University Hospital

Primary Outcome Measures

Name	Time	Method
Percentage of latent tuberculosis infection developed in Korean health care workers	Three months	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.

Secondary Outcome Measures

Name	Time	Method
Annual incidence of latent tuberculosis infection in Korean health care workers	1 year after first QFT-IT test (12-15 months)	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.

Trial Locations

Locations (1)

Hanyang University Hospital; 🇰🇷 Seoul, Korea, Republic of