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临床试验/NCT05798351
NCT05798351招募中不适用

Prevalence of Rectal Carriage of Carbapenemase Producing-Enterobacteriaceae on Admission to a French University Teaching Hospital

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 1,195 人开始时间: 2023年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,195
试验地点
1
主要终点
Percentage of patients with CPE carriage

研究概览

简要总结

"The emergence and spread of highly resistant bacteria, including carbapenemase-producing Enterobacteriaceae (CPE), is a public health challenge given their rapid spread and the lack of active antibiotics against these bacteria. The spread of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBLE) since the early 2000s raises concerns about a potential similar spread of CPE in the coming years, especially in the healthcare setting. Early detection of CPE carriage in hospitalized patients with risk factors for CPE carriage is essential to prevent their spread in hospitals as well as to guide empiric antibiotic therapy for CPE carriers with signs of severe infection. However, the prevalence of CPE carriage on admission to hospital is not precisely known, nor are factors associated with CPE carriage.

Hence, the investigators sought to determine the prevalence of CPE carriage and its risk factors in patients admitted to hospital, in order to identify the appropriate indications for CPE screening on admission to hospital. Secondly, the investigators aimed to estimate the annual number of patients with CPE carriage who would not have been identified with the current targeted screening policy as well as to estimate the annual number of secondary cases that could be prevented if a universal screening policy was applied on admission (i.e. for all hospitalized patients, not just those with risk factors).

Therefore, the investigators plan to carry out a systematic screening for rectal carriage of CPE on admission in a sample of patients hospitalized at the Bichat - Claude-Bernard Hospital. Inclusion criteria will include: Age ≥ 18 years, admission to a medical, surgical, obstetrical or intensive care unit at Bichat - Claude-Bernard Hospital in the previous 72 hours, no objection to participating in the study. Rectal swabs will be taken from all included patients for detection of CPE and/or ESBLE. Patients' characteristics, including sociodemographic data, country of birth and residence, clinical ward, current antibiotic treatment and that in the last 3 months, travel abroad and last geographical areas visited, hospitalization in France and abroad, and history of CPE and ESBLE carriage or infection in the previous year, will be collected by questionnaire and from medical records. "

详细描述

"Introduction The emergence and spread of emerging highly resistant bacteria, including carbapenemase-producing Enterobacteriaceae (CPE), is a public health challenge given their rapid spread and the lack of active antibiotics against these bacteria. The spread of extended-spectrum β-lactamase-producing Enterobacteriaceae (ESBLE) since the early 2000s raises concerns about a potential similar spread of CPE in the coming years, especially in the healthcare setting. Early detection of CPE carriage in hospitalized patients with risk factors for CPE carriage is essential to prevent their spread in hospitals as well as to guide empiric antibiotic therapy for CPE carriers with signs of severe infection. However, the prevalence of CPE carriage on admission to hospital is not precisely known, nor are factors associated with CPE carriage.

Therefore, the investigators plan to carry out a systematic screening for rectal carriage of CPE on admission in a sample of patients hospitalized at the Bichat - Claude-Bernard Hospital.

Primary objective

  • To determine the prevalence of CPE carriage in patients admitted to the Bichat - Claude-Bernard Hospital

Secondary objectives

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage of patients with CPE carriage

时间窗: 72 hours

次要结局

  • Odds ratios associated with risk factors for CPE and ESBLE carriage on admission to hospital(6 months after study start)
  • Annual number of patients with rectal CPE carriage among those with no risk factors for CPE carriage(1 year after study start)
  • Percentage of patients with ESBLE carriage(The same rectal swab will be used for detection of CPE carriage and ESBLE carriage)
  • Names and percentages of bacterial species and enzymes identified in CPE screening(6 months after study start)
  • Annual number of secondary cases of CPE carriage that could be prevented if a universal admission screening policy was implemented(1 year after study start)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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