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临床试验/NCT00177918
NCT00177918已完成不适用

Prospective Evaluations of Infectious Complications in Lung Transplant Recipients

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2006年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
600
试验地点
1
主要终点
long term outcome after lung transplantation

研究概览

简要总结

The primary aim of this study is to determine prospectively the viral and C. pneumoniae infection prevalence and outcomes of infections in lung transplant recipients. The study will also determine the correlation of C. pneumoniae infection with the development of obliterans in lung transplant recipients.

详细描述

This is a prospective cohort study of lung transplant recipients and those who will undergo lung transplantation. Patients will be identified by the pulmonologist performing the bronchoscopy. The patient's sera (obtained from a one time blood draw of 10 milliliters - two tablespoons) and cell pellet of BAL will be frozen at -70º C. Once the active or non- OB status is determined by the pathologist, stored BAL fluid (cell pellet) will be analyzed. C.pneumoniae serum titers will also be measured and compared with stored pre-transplant sera. Left over cell pellet of the BAL fluid will be used to measure the presence of C. pneumoniae by PCR method. Additionally PCR will be performed for other viruses (CMV, EBV, HHV6 & 7, human metapneumo virus and human rhino virus). In addition, during the bronchoscopy procedure as part of the patient's standard of care, a biopsy is obtained. This is done during the bronchoscopy procedure. The tissue is then sent to the pathology lab. We will collect residual (excess) tissue samples to perform research related testing. This testing will determine if we can predict other types of infections and early onset of rejection. These determinations will assist clinicians in administering appropriate dosage levels of antibiotics required to prevent or treat infections and help stop the rejection process. The subject will be asked a few questions about pulmonary symptoms that will not take more than five minutes by one of the investigators or study coordinator. The subject's medical record will be reviewed for demographic information (age, sex, and race), lab results (standard to post transplant care), medication information, as well as any testing/procedures during the transplant follow-up period. This information and results of the tests/procedures will become part of the research record.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have undergone lung transplantation or will undergo a lung transplant at the University of Pittsburgh Medical Center and are alive following transplant period will be eligible for the study.

排除标准

  • Subjects not willing to participate in the research study.

结局指标

主要结局

long term outcome after lung transplantation

时间窗: five year follow up

looking at death rate five years post lung transplantation

次要结局

未报告次要终点

研究者

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

EJ Kwak

Assistant Professor

University of Pittsburgh

研究点 (1)

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