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ClinicalTrials.gov ID

NCT07258862

Lead Sponsor

Hôpital NOVOOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

250Estimated

Last Update Posted

Dec 2, 2025Actual

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Mar 28, 2027Estimated

Completion Date

Mar 28, 2027Estimated

Official Title

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

Brief Summary

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.

Detailed Description

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.

• Catheter-Related Infections

• Inflammatory catheters: catheter removed because of infection at insertion site
• Non-inflammatory catheters: catheter removed because it is no longer relevant to keep it in place

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Observational Model

Case-Control

Time Perspective

Prospective

Lead Sponsor

Hôpital NOVOOTHER

Collaborators

Université de Cergy PontoiseUNKNOWN

damien.seyer@cyu.fr+33 1 34 25 66 96