Latent Tuberculosis Infection in Bone Marrow Transplant Recipients

Tuberculosis Clinical Trial

Official title:

A Prospective Observational Study of Usefulness of a T Cell-based Assay for Latent Tuberculosis Infection in Hematopoietic Stem Cell Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021124
• Other study ID #: 2009-0077
• Status: Completed
• Phase: N/A
• First received: November 25, 2009
• Last updated: July 17, 2013
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 409
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Age 16 or more

• Bone marrow transplant recipients

Exclusion Criteria:

• Recent contact of patients with active pulmonary tuberculosis

• Suspected active tuberculosis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of tuberculosis		after transplantation	Yes
Secondary	all cause mortality		after transplantation	Yes