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临床试验/NCT04043793
NCT04043793已完成不适用

Intensive Care Unit (ICU)-Acquired Colonization and Infection Related to Multidrug Resistant Bacteria (MDR) in Immunocompromised Patients

University Hospital, Lille7 个研究点 分布在 1 个国家目标入组 759 人开始时间: 2019年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
759
试验地点
7
主要终点
Density rate of ICU-acquired infections related to MDR in immunosuppressed patients.

研究概览

简要总结

the number of immunocompromised patients hospitalized in the intensive care units (ICU) is increasing. They are at higher risk of colonization and/or infection with multi-resistant bacteria (MDR). However this risk is not well characterized. ICU acquired infections related to MDR are associated with increased morbidity and mortality. The aim of this study is to compare the incidence of ICU-acquired colonization and ICU-acquired infection related to MDR between immunocompromized and immunocompetent patients. The risk factors for ICU-acquired colonization and ICU-acquired infections, and their impact on outcome will also be evaluated and compared between immunocompromised and immunocompetent patients.

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

  • Expected ICU stay > 48 hours
  • All patients (immunocompromised or immunocompetent).

排除标准

  • Patients aged < 18 years
  • Refusal to take part in the study
  • ICU-stay < 48 hours
  • Non availability of initial MDR or subsequent screening
  • Participation in another study that could interfere with the risk of ICU-acquired colonization and infection with MDR bacteria

结局指标

主要结局

Density rate of ICU-acquired infections related to MDR in immunosuppressed patients.

时间窗: From ICU admission until day 28 after ICU admission

the number ICU-acquired infections related to MDR will be devided by the number of days in the ICU and reported for 1000 days.

次要结局

  • Mechanical ventilation duration(From ICU admission until day 28 after ICU admission)
  • Density rate of ICU-acquired colonizations related to MDR in immunosuppressed patients(From ICU admission until day 28 after ICU admission)
  • Rate of ICU-acquired colonizations related to MDR in immunosuppressed patients.(From ICU admission until day 28 after ICU admission)
  • 28 day mortality(from ICU admission until day 28 after admission)
  • Rate of ICU-acquired infections related to MDR in immunosuppressed patients(From ICU admission until day 28 after ICU admission)
  • length of stay in intensive care unit(From ICU admission until day 28 after ICU admission)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (7)

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