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NCT01121068 Clinical Trial

Monthly Follow up of Interferon Gamma Releasing Assay (IGRA) Among Health-care Workers Treating Tuberculosis (TB) Patients

Tuberculosis Clinical Trial

Official title:
Monthly Follow up of Interferon Gamma Releasing Assay Among Health-care Workers Treating TB Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01121068
Other study ID # monthly IGRA
Secondary ID
Status Completed
Phase N/A
First received May 9, 2010
Last updated January 3, 2014
Start date May 2010
Est. completion date December 2011

Study information
Verified date January 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

Interferon gamma releasing assay(IGRA) is useful to diagnose latent tuberculosis. However,IGRA responses could show within-subject variability. We wanted to determine long-term IGRA variability in health-care workers who continuously expose to tuberculosis patients.

Description:

IGRA will be performed monthly in health-care workers with continuous exposure to tuberculosis patients for 1 year.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date December 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Health care workers who are continuously exposed to TB patients Age > 20 years

Exclusion Criteria:

- Pregnant Active TB Use of immunosuppressants

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Blood samplings
About 3.5ml of blood will be drawn from the participants monthly.

Locations
Country Name City State
Korea, Republic of Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Results of interferon-gamma releasing assay monthly for 1 year No
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