Latent Tuberculosis Infection in Bone Marrow Transplant Recipients

NCT ID: NCT01021124

Last Updated: 2013-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

409 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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QFT (+) vs QFT (-)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 16 or more
* Bone marrow transplant recipients

Exclusion Criteria

* Recent contact of patients with active pulmonary tuberculosis
* Suspected active tuberculosis
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sung-Han Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sung-Han Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee YM, Lee SO, Choi SH, Kim YS, Woo JH, Kim DY, Lee JH, Lee JH, Lee KH, Kim SH. A prospective longitudinal study evaluating the usefulness of the interferon-gamma releasing assay for predicting active tuberculosis in allogeneic hematopoietic stem cell transplant recipients. J Infect. 2014 Aug;69(2):165-73. doi: 10.1016/j.jinf.2014.02.019. Epub 2014 Mar 16.

Reference Type DERIVED
PMID: 24647146 (View on PubMed)

Moon SM, Lee SO, Choi SH, Kim YS, Woo JH, Yoon DH, Suh C, Kim DY, Lee JH, Lee JH, Lee KH, Kim SH. Comparison of the QuantiFERON-TB Gold In-Tube test with the tuberculin skin test for detecting latent tuberculosis infection prior to hematopoietic stem cell transplantation. Transpl Infect Dis. 2013 Feb;15(1):104-9. doi: 10.1111/j.1399-3062.2012.00765.x. Epub 2012 Jul 23.

Reference Type DERIVED
PMID: 22823749 (View on PubMed)

Other Identifiers

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2009-0077

Identifier Type: -

Identifier Source: org_study_id

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