We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT01021124
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : July 18, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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
Tuberculosis

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 Design

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
Primary Completion Date : June 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
QFT (+) vs QFT (-)


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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

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 ClinicalTrials.gov identifier (NCT number): 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

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
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:
tuberculosis
bone marrow transplant
diagnosis

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