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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHôpital NOVO

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patient hospitalized in a care unit of the NOVO hospital

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Inflammatory catheters: catheter removed because of infection at insertion site

    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

    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

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Inflammatory catheters1 intervention
Group B: Non-inflammatory catheters1 intervention

Trial outcomes

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.

Time frame
15 months

Secondary outcomes

1

Biofilms structural morphology in PVCs

Qualitative imaging of microbial biofilms in PVCs using Scanning Electron Microscopy

Time frame
15 months
2

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

Time frame
15 months
3

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.

Time frame
15 months

Other outcomes

Sponsors and contacts

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Hôpital NOVO

Lead sponsor

Université de Cergy Pontoise

Collaborator

This trial is not recruiting at the moment. You can still explore other options: