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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Joon Yim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01121068
First received: May 9, 2010
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Tuberculosis
Other: Blood samplings

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monthly Follow up of Interferon Gamma Releasing Assay Among Health-care Workers Treating TB Patients

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Results of interferon-gamma releasing assay [ Time Frame: monthly for 1 year ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Health care workers Other: Blood samplings
About 3.5ml of blood will be drawn from the participants monthly.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Health care workers who are continuously exposed to TB patients

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant Active TB Use of immunosuppressants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121068

Locations
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, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Jae-Joon Yim, MD Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jae-Joon Yim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01121068     History of Changes
Other Study ID Numbers: monthly IGRA
Study First Received: May 9, 2010
Last Updated: January 3, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
IGRA
variability
Long-term variability of IGRA

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Interferon-gamma
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014