Latent Tuberculosis Infection in Bone Marrow Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01021124
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : July 18, 2013
Information provided by (Responsible Party):
Sung-Han Kim, Asan Medical Center

Brief Summary:
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 or disease

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.

Study Type : Observational
Actual Enrollment : 409 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

QFT (+) vs QFT (-)

Primary Outcome Measures :
  1. development of tuberculosis [ Time Frame: after transplantation ]

Secondary Outcome Measures :
  1. all cause mortality [ Time Frame: after transplantation ]

Biospecimen Retention:   Samples Without DNA
whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Bone marrow transplant recipients

Inclusion Criteria:

  • Age 16 or more
  • Bone marrow transplant recipients

Exclusion Criteria:

  • Recent contact of patients with active pulmonary tuberculosis
  • Suspected active tuberculosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01021124

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sung-Han Kim, Assistant Professor, Asan Medical Center Identifier: NCT01021124     History of Changes
Other Study ID Numbers: 2009-0077
First Posted: November 26, 2009    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013

Keywords provided by Sung-Han Kim, Asan Medical Center:
bone marrow transplant

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