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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07258862
Acronym
KTBIO
Enrollment
250
Registered
2025-12-02
Start date
2026-01-01
Completion date
2027-03-28
Last updated
2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-Related Infections

Keywords

Vascular Access Devices, Peripheral Venous Catheter, Catheter-Related Infections, Biofilms, Molecular Biology, Next-Generation Sequencing, Scanning Electron Microscopy

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.

Interventions

DIAGNOSTIC_TESTInflammatory 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

DEVICENon-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

Sponsors

Université de Cergy Pontoise
CollaboratorUNKNOWN
Hôpital NOVO
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Bacterial diversity of biofilms in PVCs according to inflammatory symptoms15 monthsRelative abundance of bacteria within biofilms present in CVPs as identified by NGS, according to inflammatory symptoms.

Secondary

MeasureTime frameDescription
Biofilms structural morphology in PVCs15 monthsQualitative imaging of microbial biofilms in PVCs using Scanning Electron Microscopy
Bacterial diversity of biofilms in PVCs according to type of substances administered through the vascular route15 monthsRelative 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
Bacterial diversity of biofilms in PVCs according to catheter dwell time15 monthsRelative abundance of bacteria within biofilms present in CVPs as identified by NGS, according to catheter dwell time.

Countries

France

Contacts

Primary ContactMaryline DELATTRE
maryline.delattre@ght-novo.fr+33130755031
Backup ContactMarylise ADECHIAN
marylise.adechian@ght-novo.fr+33130755069

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026