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临床试验/NCT02623413
NCT02623413Unknown不适用

Cohort Study of German Hematological / Oncological Wards to Assess the Effect of Contact Precautions on Nosocomial Colonization With Vancomycin Resistant Enterococci

University of Cologne0 个研究点目标入组 950 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
950
主要终点
Incidence of hospital-acquired VRE-colonization and/or infection

研究概览

简要总结

The study aims to evaluate the impact of contact precautions on the rate of VRE- the rate of colonization and infection aand hospital-acquired VRE transmissions.

Hematological and oncological wards in hospitals with a non-outbreak setting for VRE and adhering to at least the following standard of care are eligible for study participation:

Fecal screening for the presence of VRE of all patients within 72 hours of each admission by use of a rectal swab or stool sample Follow-up fecal screening once a week and within 72 hours of discharge Implementation of clinical standards aimed at VRE decolonization is not allowed on wards participating in this study, including in the context of clinical studies.

Sites will be grouped according to their approach regarding contact isolation (see group description).

As a control for external factors a hand hygiene program, including training and adherence assessments, will be implemented.

This observational study prospectively compares wards with different approaches to isolation. All screening and isolation measures are already in place on participating wards (i.e. constituted a site selection criterion) and are exclusively implemented as part of the standard of care. Sites are free to adjust their standard of care as they see fit. No intervention will be performed.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of hospital-acquired VRE-colonization and/or infection

时间窗: 1 year

次要结局

  • Incidence of patient-to-patient transmission of VRE(1 year)
  • Incidence of VRE intestinal colonization among all patients(1 year)
  • Incidence of VRE bloodstream infections among previously colonized patients(1 year)
  • Incidence of VRE bloodstream infections among all patients(1 year)
  • Readmission fraction associated with VRE infection(1 year)
  • Prevalence of VRE in the community.(1 year)

研究者

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

Maria J.G.T. Vehreschild

PD Dr.

University of Cologne

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