Analysis of Microbial Biofilms in Peripheral Venous Catheters and Their Implication in Infectious Risk
KTBIO
2 other identifiers
observational
250
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2025
CompletedFirst Posted
Study publicly available on registry
December 2, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 28, 2027
December 2, 2025
November 1, 2025
1.2 years
November 21, 2025
November 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Biofilms structural morphology in PVCs
15 months
Bacterial diversity of biofilms in PVCs according to type of substances administered through the vascular route
15 months
Bacterial diversity of biofilms in PVCs according to catheter dwell time
15 months
Study Arms (2)
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
Interventions
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
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
Eligibility Criteria
Patient hospitalized in a care unit of the NOVO hospital
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hôpital NOVOlead
- Université de Cergy Pontoisecollaborator
Study Sites (2)
Hopital Novo
Cergy-Pontoise, Hopital NOVO, 95303, France
CY Cergy Paris Université
Neuville-sur-Oise, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
LECURU Marion, Doctor
Hôpital NOVO
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2025
First Posted
December 2, 2025
Study Start
January 1, 2026
Primary Completion (Estimated)
March 28, 2027
Study Completion (Estimated)
March 28, 2027
Last Updated
December 2, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share