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Latent Tuberculosis Infection in Bone Marrow Transplant Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sung-Han Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01021124
First received: November 25, 2009
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

The aim of this study is to estimate the usefulness of a T cell-based assay (i.e. Quantiferon-Gold In-Tube assay) for diagnosis of latent tuberculosis infection (LTBI) in bone marrow transplant recipients. For this purpose, the investigators enrolled bone marrow transplant recipients and observed the developement of tuberculosis after the transplantation.


Condition
Tuberculosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Hematopoietic Stem Cell Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • development of tuberculosis [ Time Frame: after transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • all cause mortality [ Time Frame: after transplantation ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

whole blood


Enrollment: 409
Study Start Date: January 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
QFT (+) vs QFT (-)

Detailed Description:

All adult bone marrow transplant recipients admitted to Asan Medical Center will be enrolled.

Quantiferon-Gold In-Tube assay will be performed.

Isoniazid prophylaxis will be given only to patients with clinical risk factors (i.e. recent contact with active pulmonary TB patient or inadequate treatment history with abnormal CXR). However, isoniazid prophylaxis will be not given based on positive TST or positive Quantiferon-Gold In-Tube assay.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Bone marrow transplant recipients

Criteria

Inclusion Criteria:

  • Age 16 or more
  • Bone marrow transplant recipients

Exclusion Criteria:

  • Recent contact of patients with active pulmonary tuberculosis
  • Suspected active tuberculosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021124

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Sung-Han Kim, MD Asan Medical Center
  More Information

No publications provided by Asan Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sung-Han Kim, Assistant Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01021124     History of Changes
Other Study ID Numbers: 2009-0077
Study First Received: November 25, 2009
Last Updated: May 14, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
tuberculosis
bone marrow transplant
diagnosis

Additional relevant MeSH terms:
Tuberculosis
Latent Tuberculosis
Mycobacterium Infections
 Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 16, 2013