NCT07258862

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: Hôpital NOVO · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-03-28
• Completion: 2027-03-28
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

2 sites across 1 country: France