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临床试验/NCT04377139
NCT04377139Unknown不适用

Observational, Epidemiological, Retrospective Study of the Management of CMV Infection in a Cohort of Patients Receiving Lung Transplantation in Spain

Hospital Universitari Vall d'Hebron Research Institute0 个研究点目标入组 1,500 人开始时间: 2020年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,500
主要终点
CMV infection and/or disease

研究概览

简要总结

Background: Lung transplant recipients (LTR) have the highest risk of CMV infection. CMV pneumonitis, lymphocytic bronchitis, and detection of CMV DNA in bronchoalveolar lavage fluid are independent risk factors for the development of chronic lung allograft dysfunction (CLAD). However, to demonstrate the clinical impact of the indirect effects of CMV, it is necessary to conduct studies with a very large sample size.

Hypothesis: The different current preventive strategies for CMV infection in LTR and their clinical application on a daily basis impact on the development of direct and indirect effects of CMV in this population.

Objectives: To study the effect of CMV infection on LTR in relation to current preventive strategies in terms of:

  • The incidence of acute and chronic rejection
  • The incidence of other opportunistic infections
  • The incidence of neoplastic disease, especially, post-transplant lymphoproliferative disease
  • Patient and graft survival Methods: Multicenter, retrospective, cohort study. Consecutive inclusion of all adult lung transplant recipients from 2013 to 2017 with 2 years of follow-up. The investigators will collect and analyze the main clinical and microbiological variables in order to respond to the objectives of the study.

Relevance: Knowing in detail the current epidemiology of CMV infection in LTR and its subsequent influence on both mortality and the presence of different complications, could allow improving the management of these patients in the future.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • · Survival > 1 month post-transplant
  • High to moderate risk patients to develop CMV disease by means of pre-transplant CMV serology:
  • Donor positive to recipient negative
  • Recipient positive independently of donor serology

排除标准

  • Survival < 1 month after procedure
  • Low risk serology to develop CMV disease: both donor and recipient seronegative

结局指标

主要结局

CMV infection and/or disease

时间窗: Two-year follow-up

Incidence

次要结局

  • Graft rejection both acute or CLAD(Two-year follow-up)

研究者

申办方类型
Other
责任方
Sponsor

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