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临床试验/NCT01021124
NCT01021124已完成不适用

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

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 409 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
409
试验地点
1
主要终点
development of tuberculosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 16 or more
  • Bone marrow transplant recipients

排除标准

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

结局指标

主要结局

development of tuberculosis

时间窗: after transplantation

次要结局

  • all cause mortality(after transplantation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sung-Han Kim

Assistant Professor

Asan Medical Center

研究点 (1)

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