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临床试验/NCT07258862
NCT07258862尚未招募不适用

Analysis of Microbial Biofilms in Peripheral Venous Catheters and Their Implication in Infectious Risk

Hôpital NOVO2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
250
试验地点
2
主要终点
Bacterial diversity of biofilms in PVCs according to inflammatory symptoms

研究概览

简要总结

Peripheral venous catheters (PVCs) are the most commonly used intravascular medical devices in healthcare establishments. Although essential in patient care, PVCs represent a significant risk factor for nosocomial infections, as shown by the results of the national prevalence survey. While the main pathophysiological mechanisms are known, the specific factors driving the transition from simple colonization to infection remain unclear. This project aims to identify the major factors involved in the occurrence of bacterial infections related to the colonization of peripheral venous catheters.

详细描述

Peripheral venous catheters (PVCs) are the most commonly used intravascular medical devices in healthcare establishments. In the 2022 national survey on the prevalence of nosocomial infections (NI), out of 151676 patients included, 22.45% had a peripheral venous catheter. Moreover, patients exposed to a PVC are 3 times more likely to suffer a nosocomial infection. Between 2019 and 2023, at national level, there was a significant increase in the proportion of PVC-related bloodstream infection. The pathophysiological mechanisms of catheter-related infections are mainly linked to contamination via the endoluminal route, through manipulations of connectors during perfusion connections, or via the extraluminal route, which is more likely to be associated with faulty catheter placement practices. Finally, even in patients with no clinical signs of infection, culture-negative PVCs show intra- and extra-luminal colonization.

This underscores our lack of understanding of the mechanisms that can lead from simple colonization of the equipment to localized catheter infection or even bacteraemia.

The main objective of this project is to identify the major factors involved in the occurrence of bacterial infections related to the colonization of peripheral venous catheters.

To investigate these mechanisms, the study will focus on the collection of PVCs after clinical removal, followed by molecular and super-resolution microscopy analyses. Catheters either removed by the care team, because they are no longer clinically relevant or for medical reasons, will be collected under aseptic conditions.

研究设计

研究类型
Observational
观察模型
Case Control
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 a care unit of the NOVO hospital (Pontoise site)
  • Major patient for whom a peripheral venous catheter has been in place for at least 2 days and at most 7 days, with or without signs of inflammation

排除标准

  • Antibiotic treatment by any route
  • Patient with viral hepatitis, or human immunodeficiency virus (HIV) or suspected epidemic and biological risk (EBR)
  • Patient unable to understand and give non-opposition to study participation
  • Patient under guardianship

结局指标

主要结局

Bacterial diversity of biofilms in PVCs according to inflammatory symptoms

时间窗: 15 months

Relative abundance of bacteria within biofilms present in CVPs as identified by NGS, according to inflammatory symptoms.

次要结局

  • Biofilms structural morphology in PVCs(15 months)
  • Bacterial diversity of biofilms in PVCs according to type of substances administered through the vascular route(15 months)
  • Bacterial diversity of biofilms in PVCs according to catheter dwell time(15 months)

研究者

发起方
Hôpital NOVO
申办方类型
Other
责任方
Sponsor

研究点 (2)

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