Latent Tuberculosis Infection in Bone Marrow Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sung-Han Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01021124
First received: November 25, 2009
Last updated: July 17, 2013
Last verified: July 2013

November 25, 2009
July 17, 2013
January 2010
June 2013   (final data collection date for primary outcome measure)
development of tuberculosis [ Time Frame: after transplantation ] [ Designated as safety issue: Yes ]
development of tuberculosis [ Time Frame: within 2 years after transplantation ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01021124 on ClinicalTrials.gov Archive Site
all cause mortality [ Time Frame: after transplantation ] [ Designated as safety issue: Yes ]
all cause mortality [ Time Frame: within 2 years after transplantation ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Latent Tuberculosis Infection in Bone Marrow Transplant Recipients
A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Hematopoietic Stem Cell Transplant Recipients

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood

Probability Sample

Bone marrow transplant recipients

Tuberculosis
Not Provided
QFT (+) vs QFT (-)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
409
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 16 or more
  • Bone marrow transplant recipients

Exclusion Criteria:

  • Recent contact of patients with active pulmonary tuberculosis
  • Suspected active tuberculosis
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01021124
2009-0077
Yes
Sung-Han Kim, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Sung-Han Kim, MD Asan Medical Center
Asan Medical Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP