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

NCT ID: NCT07258862

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-03-28

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.

Conditions

Catheter-Related Infections

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Inflammatory catheters

Catheter removed because of infection at insertion site

Inflammatory catheters: catheter removed because of infection at insertion site

Intervention Type: DIAGNOSTIC_TEST

Verification of inclusion and non-inclusion criteria (at least 2 days and at most 7 days, with or without signs of inflammation).

The doctor or a qualified nurse orally informs the patient when catheter removal is planned.

The information and non-opposition note are given to the patient, and the information procedure is recorded in the medical record.

The catheter is removed and collected under aseptic conditions by the nurses in the various departments, in a dry sterile tube. The tube is then labelled and stored at a maximum of 4°C. The catheter is sent to the hospital's biology laboratory before being collected by the approved carrier for delivery to the ERRMECe laboratory from CYU. All tests are performed in the ERRMECe laboratory. Collected catheters are subsequently analysed to assess the bacterial diversity of biofilms using molecular biology techniques and Next-Generation Sequencing (NGS), in parallel with biofilm structural analysis microscopy using a Scanning Electron Microsc

Non-inflammatory catheters

catheter removed because it is no longer relevant to keep it in place

Non-inflammatory catheters: catheter removed because it is no longer relevant to keep it in place

Intervention Type: DEVICE

Verification of inclusion and non-inclusion criteria (at least 2 days and at most 7 days, with or without signs of inflammation).

The doctor or a qualified nurse orally informs the patient when catheter removal is planned.

The information and non-opposition note are given to the patient, and the information procedure is recorded in the medical record.

The catheter is removed and collected under aseptic conditions by the nurses in the various departments, in a dry sterile tube. The tube is then labelled and stored at a maximum of 4°C. The catheter is sent to the hospital's biology laboratory before being collected by the approved carrier for delivery to the ERRMECe laboratory from CYU. All tests are performed in the ERRMECe laboratory. Collected catheters are subsequently analysed to assess the bacterial diversity of biofilms using molecular biology techniques and Next-Generation Sequencing (NGS), in parallel with biofilm structural analysis microscopy using a Scanning Electron Microsc

Interventions

Inflammatory catheters: catheter removed because of infection at insertion site

Verification of inclusion and non-inclusion criteria (at least 2 days and at most 7 days, with or without signs of inflammation).

The doctor or a qualified nurse orally informs the patient when catheter removal is planned.

The information and non-opposition note are given to the patient, and the information procedure is recorded in the medical record.

The catheter is removed and collected under aseptic conditions by the nurses in the various departments, in a dry sterile tube. The tube is then labelled and stored at a maximum of 4°C. The catheter is sent to the hospital's biology laboratory before being collected by the approved carrier for delivery to the ERRMECe laboratory from CYU. All tests are performed in the ERRMECe laboratory. Collected catheters are subsequently analysed to assess the bacterial diversity of biofilms using molecular biology techniques and Next-Generation Sequencing (NGS), in parallel with biofilm structural analysis microscopy using a Scanning Electron Microsc

Intervention Type: DIAGNOSTIC_TEST

Non-inflammatory catheters: catheter removed because it is no longer relevant to keep it in place

Verification of inclusion and non-inclusion criteria (at least 2 days and at most 7 days, with or without signs of inflammation).

The doctor or a qualified nurse orally informs the patient when catheter removal is planned.

The information and non-opposition note are given to the patient, and the information procedure is recorded in the medical record.

The catheter is removed and collected under aseptic conditions by the nurses in the various departments, in a dry sterile tube. The tube is then labelled and stored at a maximum of 4°C. The catheter is sent to the hospital's biology laboratory before being collected by the approved carrier for delivery to the ERRMECe laboratory from CYU. All tests are performed in the ERRMECe laboratory. Collected catheters are subsequently analysed to assess the bacterial diversity of biofilms using molecular biology techniques and Next-Generation Sequencing (NGS), in parallel with biofilm structural analysis microscopy using a Scanning Electron Microsc

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Université de Cergy Pontoise

UNKNOWN

Sponsor Role: collaborator

Hôpital NOVO

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LECURU Marion, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hôpital NOVO

Locations

Hopital Novo

Cergy-Pontoise, Hopital NOVO, France

CY Cergy Paris Université

Neuville-sur-Oise, , France

Countries

France

Central Contacts

Maryline DELATTRE

Role: CONTACT

maryline.delattre@ght-novo.fr

+33130755031

Marylise ADECHIAN

Role: CONTACT

marylise.adechian@ght-novo.fr

+33130755069

Facility Contacts

Maryline DELATTRE

Role: primary

promotion-usrc@ght-novo.fr

+33130754131

DELATTRE

Role: backup

SEYER Damien, Phd

Role: primary

damien.seyer@cyu.fr

+33 1 34 25 66 96

Other Identifiers

202509 - 011

Identifier Type: OTHER

Identifier Source: secondary_id

CHRD1025

Identifier Type: -

Identifier Source: org_study_id