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临床试验/NCT02260596
NCT02260596已完成不适用

A Multicenter Consortium to Define the Epidemiology and Outcomes of Respiratory Viral Infections in Pediatric Transplant Recipients

Duke University1 个研究点 分布在 1 个国家目标入组 2,669 人开始时间: 2014年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,669
试验地点
1
主要终点
Incidence of respiratory viral infection

研究概览

简要总结

A retrospective cohort of solid organ transplant (SOT) and hematopoietic stem cell transplant (HSCT) recipients will be assembled to determine the incidence of respiratory viral infections diagnosed during an inpatient admission in the first year post-transplant. A sub-cohort of patients that develop a respiratory viral infection within one year of transplantation will be leveraged to investigate factors associated with mortality in the three months after respiratory viral infection.

详细描述

The purpose of the study is to 1) Determine the incidence of respiratory viral infections diagnosed during the first year post SOT and HSCT; 2a) Determine the all-cause mortality within 3 months of a respiratory viral infection diagnosed during an inpatient admission in the first year post SOT and HSCT; 2b) Determine the proportion of deaths within 3 months of a respiratory viral infection diagnosed during an inpatient admission deemed to be directly attributable to that infection; and 3) To identify factors known at time of onset of the inpatient respiratory viral infection that are associated with all-cause mortality. The study cohort will consist of any SOT or HSCT recipient ≤18 years of age that received their transplant between January 1st, 2010 and June 30th, 2013. Th cohort will determine the incidence of respiratory viral infections diagnosed during an inpatient admission in the first year post-transplant. A sub-cohort of patients that develop a respiratory viral infection within one year of transplantation will be leveraged to investigate factors associated with mortality in the 3 months after respiratory viral infection. Baseline and demographic characteristics will be summarized by standard descriptive summaries. Categorical variables will be summarized by frequencies while continuous variables will be summarized using mean, standard deviation and/or median, twenty-fifth and seventy-fifth percentiles, minimum, and maximum. This is a minimal risk study using data that will be collected retrospectively from medical charts. The only potential risk would be loss of confidentiality.

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

入选标准

  • Males or females age 0 to <18 years at the time of HSCT or SOT
  • Transplantation occurred between January 1st, 2010 and June 30th, 2013.

排除标准

  • 未提供

结局指标

主要结局

Incidence of respiratory viral infection

时间窗: 1 year post transplant

Pediatric SOT/HSCT recipients who do not develop respiratory viral infection within 1 year following transplant

次要结局

  • All-cause mortality of respiratory viral infection(3 months after respiratory viral infection)

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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