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临床试验/NCT04637321
NCT04637321已完成不适用

Everyone Poops: An Evaluation of the Incidence and Risk Factors for Clostridioides Difficle Infection in Solid Organ Transplant Recipients

Methodist Health System1 个研究点 分布在 1 个国家目标入组 585 人开始时间: 2019年11月4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
585
试验地点
1
主要终点
Risk factors for CDI post-transplant - No.2

研究概览

简要总结

2.1. Study Objectives

  • Primary Objective(s)
  • Identify the incidence and risk of CDI within one year after kidney, liver, and/or pancreas transplant
  • Secondary Objective(s)
  • Identify the risk factors for recurrent CDI post-transplant in patients who were diagnosed with a CDI within one year prior to Solid Organ Transplant
  • Evaluate the impact of CDI on graft survival following Solid Organ Transplant

详细描述

  • Single center, retrospective cohort chart review study design
  • Data will be collected on all liver, kidney, pancreas and combined transplant recipients who received their graft(s) from April 1, 2015 to July 31, 2018
  • Will analyze outcomes from April 1, 2014 to July 31, 2019
  • Patient list will be generated in Epic and Meditech
  • All data will be obtained from Epic and Meditech
  • All data will be collected retrospectively after the patient is discharged from the hospital

研究设计

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

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

  • Solid organ transplant patients who received graft(s) at MDMC from April 1, 2015 to July 31, 2018
  • Age >18 years old

排除标准

  • Age <18 years old
  • Loss to early death defined as within one week from transplantation
  • Patients whose primary address is in Puerto Rico

结局指标

主要结局

Risk factors for CDI post-transplant - No.2

时间窗: April 1, 2014 to July 31, 2019

Origin of transplanted graft including age of donor

Risk factors for CDI post-transplant No. 12

时间窗: April 1, 2014 to July 31, 2019

Antibiotic use in the 90 days post-transplant

Incidence of C. Difficile infection (CDI) within one year post-transplant

时间窗: April 1, 2014 to July 31, 2019

Incidence of C. Difficile infection within one year post-transplant for CDI post-transplant.

Risk factors for CDI post-transplant No.7

时间窗: April 1, 2014 to July 31, 2019

Co-infection with HIV/AIDS

Risk factors for CDI post-transplant - No.1

时间窗: April 1, 2014 to July 31, 2019

Risk factors transplanted organ

Risk factors for CDI post-transplant No.4

时间窗: April 1, 2014 to July 31, 2019

Acid suppression

Risk factors for CDI post-transplant No.5

时间窗: April 1, 2014 to July 31, 2019

First time SOT recipient

Risk factors for CDI post-transplant No.-3

时间窗: April 1, 2014 to July 31, 2019

Induction agent used

Risk factors for CDI post-transplant No.6

时间窗: April 1, 2014 to July 31, 2019

History of CDI in the year prior to transplant

Risk factors for CDI post-transplant No.8

时间窗: April 1, 2014 to July 31, 2019

Length of hospital stay

Risk factors for CDI post-transplant No. 9

时间窗: April 1, 2014 to July 31, 2019

Length of intensive care unit stay

Risk factors for CDI post-transplant No.10

时间窗: April 1, 2014 to July 31, 2019

Intra-operative administration of blood products

Risk factors for CDI post-transplant No. 11

时间窗: April 1, 2014 to July 31, 2019

Antibiotic use in the 90 days prior to infection

Risk factors for CDI post-transplant No, 13

时间窗: April 1, 2014 to July 31, 2019

Hospitalization in the 90 days prior to transplantation

Risk factors for CDI post-transplant No, 14

时间窗: April 1, 2014 to July 31, 2019

Hospitalization in the 90 days post-transplant

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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