Diagnostic Usefulness of Interferon Gamma Release Assay for Active Tuberculosis in Immunocompromised Patients

This study has been completed.

First Received on August 19, 2009. Last Updated on January 31, 2012 History of Changes

Sponsor:	Yonsei University
Information provided by (Responsible Party):	Yonsei University
ClinicalTrials.gov Identifier:	NCT00962676

Purpose

For diagnosis of active tuberculosis, interferon-γ release assay based mycobacterium tuberculosis specific antigen may show higher sensitivity than tuberculin skin test in immunocompromised patients. Therefore, interferon-γ release assay have a role as a rapid diagnostic adjunctive methods for active tuberculosis in immunocompromised patients.

Condition
Tuberculosis

Study Type:

Observational

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Further study details as provided by Yonsei University:

Enrollment:	140
Study Start Date:	July 2009
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
immunocompromised group
non-immunocompromised group

Eligibility

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

Study Population

suspicious of tuberculosis, immunocompromised patients such cancer patients on chemotherapy, transplantation patients, patients with immunosuppressant

Criteria

Inclusion Criteria:

Patient suspicious of active tuberculosis with immunocompromised condition
Immunocompromised condition patients with
1. solid cancer with chemotherapy
2. hematologic malignancy
3. organ transplantation
4. immunosuppressant
5. ESRD on renal replacement therapy
6. diabetes
7. advanced liver cirrhosis

Exclusion Criteria:

Patients with
1. less than 20 years
2. who don't agree the participation of study
3. hypersensitivity history to tuberculin
4. pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962676

Locations

Korea, Republic of
Yonsei Univ.
Seoul, Korea, Republic of

Sponsors and Collaborators

Yonsei University

More Information

No publications provided

Responsible Party:	Yonsei University
ClinicalTrials.gov Identifier:	NCT00962676 History of Changes
Other Study ID Numbers:	4-2009-0129
Study First Received:	August 19, 2009
Last Updated:	January 31, 2012
Health Authority:	Korea: Food and Drug Administration; Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Yonsei University:

suspicious of tuberculosis
immunocompromised patients

Additional relevant MeSH terms:

Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on February 09, 2012