跳至主要内容
临床试验/NCT01562769
NCT01562769终止不适用

Interest of Contact Precautions for Preventing Micro-organisms Acquisition in Patients Hospitalized in Infectious Disease Unit of University-affiliated Hospital in Rennes

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
400
试验地点
1
主要终点
Acquisition rate of micro-organisms

研究概览

简要总结

Application of isolation (=contact precautions) in hospitalized patients is recommended when patient is colonized (or infected) by micro-organism known for its outbreak capacity or high pathogenicity. It allows the reinforcement of universal precautions (=standard precautions) in order to control patient-to-patient micro-organisms transmission. Recently, the efficacy of this measure is questioned and its impact on patient care seems deleterious.

In a particular context of Infectious Disease Unit, where standard precautions are handled (favorable architecture and appropriate practice for hand hygiene), assessment of contact precautions to reduce the incidence of acquired bacteria during hospitalization would be of interest.

The investigators design a non-inferiority comparative study to measure the colonization pressure in patients hospitalized in two different parts of the department: one unit only with standard precautions applied (intervention) and one unit with contact precautions (control) as current routine care.

研究设计

研究类型
Observational
观察模型
Case Crossover
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

  • Patient hospitalized in Infectious Diseases Unit during the study period in one of the selected part of the unit participating to the study
  • Patient informed about the study protocol and approved to participate.

排除标准

  • Patient requiring isolation prescription type "air" or "droplet"
  • Patient hospitalized in the central sector of the building (including 4 bedrooms in depression negative service)
  • Patient colonized with bacteria producing carbapenemase, multi-resistant Acinetobacter baumanii or Vancomycin-Resistant Enterococcus.
  • Patients under legal protection (juridical protection, legal guardianship) or persons on juridical detention.

结局指标

主要结局

Acquisition rate of micro-organisms

时间窗: 2 years

Acquisition rate using bacteriological sampling (nose and anus) at admission and at the day of discharge in each patient hospitalized in the department.

次要结局

  • Utilization of aprons and gloves in each group(2 years)
  • Number of infections acquired during hospitalization in each group(2 years)
  • Consumption of hydro-alcoholic rub in each group(2 years)

研究者

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

研究点 (1)

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