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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Catheter-Related Infections
• Intervention / Treatment: Diagnostic test: Inflammatory catheters: catheter removed because of infection at insertion site; Device: Non-inflammatory catheters: catheter removed because it is no longer relevant to keep it in place

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Maryline DELATTRE; Phone Number: +33130755031; Email: maryline.delattre@ght-novo.fr
• Study Contact Backup: Name: Marylise ADECHIAN; Phone Number: +33130755069; Email: marylise.adechian@ght-novo.fr

Study Locations

• France
  • Neuville-sur-Oise, France
    • CY Cergy Paris Université
    • Contact: SEYER Damien, Phd; Phone Number: +33 1 34 25 66 96; Email: damien.seyer@cyu.fr
  • Hopital NOVO
    • Cergy-Pontoise, Hopital NOVO, France, 95303
      • Hôpital NOVO
      • Contact: Maryline DELATTRE; Phone Number: +33130754131; Email: promotion-usrc@ght-novo.fr
      • Contact: DELATTRE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient hospitalized in a care unit of the NOVO hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inflammatory catheters; Catheter removed because of infection at insertion site	Diagnostic test: 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
Non-inflammatory catheters; catheter removed because it is no longer relevant to keep it in place	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial diversity of biofilms in PVCs according to inflammatory symptoms	Relative abundance of bacteria within biofilms present in CVPs as identified by NGS, according to inflammatory symptoms.	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biofilms structural morphology in PVCs	Qualitative imaging of microbial biofilms in PVCs using Scanning Electron Microscopy	15 months
Bacterial diversity of biofilms in PVCs according to type of substances administered through the vascular route	Relative abundance of bacteria within biofilms present in PVCs as identified by NGS, according to the type of substances received by patients through the vascular route	15 months
Bacterial diversity of biofilms in PVCs according to catheter dwell time	Relative abundance of bacteria within biofilms present in CVPs as identified by NGS, according to catheter dwell time.	15 months

Collaborators and Investigators

• Sponsor: Hôpital NOVO
• Collaborators: Université de Cergy Pontoise
• Investigators: Principal Investigator: LECURU Marion, Doctor, Hôpital NOVO

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): March 28, 2027

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Next-Generation Sequencing; Molecular Biology; Vascular Access Devices; Catheter-Related Infections; Biofilms; Peripheral Venous Catheter; Scanning Electron Microscopy
• Additional Relevant MeSH Terms: Infections; Catheter-Related Infections
• Other Study ID Numbers: CHRD1025; 202509 - 011 (Other Identifier: Université Cergy Pontoise)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No