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临床试验/NCT07345923
NCT07345923招募中不适用

Predictive Value of a Rectal Swab With Detection of Enterobacteria (ESBL-E), Carbapenemases, and High-level Cephalosporinase (HLC) on the Risk of Infections With C3G-resistant Enterobacteria in Intensive Care

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2025年10月6日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Negative predictive value of a negative rectal swab for the risk of infection with ESBL-producing Enterobacteriaceae

研究概览

简要总结

The objective of the research is to evaluate the value of testing for ESBL carriage by rectal swab to predict the risk of ESBL-producing Enterobacteriaceae infections in intensive care.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Adult patients (≥ 18 years old)
  • Who have been in medical or surgical intensive care at Strasbourg University Hospitals (between January 1, 2024, and January 1, 2025)
  • Who have undergone rectal screening for carriage of ESBL/HLC/carbapenemase-producing Enterobacteriaceae

排除标准

  • Refusal to participate in the study

结局指标

主要结局

Negative predictive value of a negative rectal swab for the risk of infection with ESBL-producing Enterobacteriaceae

时间窗: Up to 12 months

The negative predictive value (NPV) answers the following question: When the test is negative, what is the probability that the person will not develop an infection with these resistant bacteria? For example: * Out of 100 people with a negative smear test, * if 95 never develop an infection, then the negative predictive value is 95%.

次要结局

未报告次要终点

研究者

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

研究点 (1)

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