Latent Tuberculosis Infection in Korean Health Care Workers

NCT03010111 | Unknown DMC

• 1 other identifier: HYUMC_CM_001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Latent Tuberculosis

Keywords

Latent Tuberculosis; Interferons; Tuberculosis; Healthcare

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Annual incidence of latent tuberculosis infection in Korean health care workers

  1 year after first QFT-IT test (12-15 months)

Study Arms (1)

health care workers

OTHER

health care workers including doctors, nurses, technicians and orderly who were hired in 2016 at the Hanyang University Hospital

Other: QFT-IT Test and other blood sampling

Interventions

QFT-IT Test and other blood sampling OTHER

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

health care workers

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Health care workers in University affiliated hospital
• Adult aged 20-65

You may not qualify if:

• Active tuberculosis
• Subjects diagnosed with HIV infection, malignancy
• Subjects having immunosuppressive drug therapy

Sponsors & Collaborators

• Hanyang University: lead

Study Sites (1)

Hanyang University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Jang Won Shon, M.D., Ph.D.

  Hanyang University Hospital, Seoul, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Won Park, M.D., Ph.D.

CONTACT

portrayme@hanmail.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: December 17, 2016
• First Posted: January 4, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 4, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)