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

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT00962676
Collaborator
(none)
140
Enrollment
1
Location
17
Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    140 participants
    Study Start Date :
    Jul 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Dec 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    immunocompromised group
    non-immunocompromised group

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Yonsei Univ. Seoul Korea, Republic of

      Sponsors and Collaborators

      • Yonsei University

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Yonsei University
      ClinicalTrials.gov Identifier:
      NCT00962676
      Other Study ID Numbers:
      • 4-2009-0129
      First Posted:
      Aug 20, 2009
      Last Update Posted:
      Feb 2, 2012
      Last Verified:
      Jan 1, 2012
      Keywords provided by Yonsei University
      suspicious of tuberculosis
      immunocompromised patients
      Additional relevant MeSH terms:
      Tuberculosis

      Study Results

      No Results Posted as of Feb 2, 2012