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NCT Number: NCT07258862

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

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.

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Key information

Conditions

Catheter-Related Infections Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Novo, Cergy-Pontoise, Hopital NOVO, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Bacterial diversity of biofilms in PVCs according to inflammatory symptoms

    Time frame: 15 months

    Relative abundance of bacteria within biofilms present in CVPs as identified by NGS, according to inflammatory symptoms.

Secondary outcomes

  1. Biofilms structural morphology in PVCs

    Time frame: 15 months

    Qualitative imaging of microbial biofilms in PVCs using Scanning Electron Microscopy

  2. Bacterial diversity of biofilms in PVCs according to type of substances administered through the vascular route

    Time frame: 15 months

    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

  3. Bacterial diversity of biofilms in PVCs according to catheter dwell time

    Time frame: 15 months

    Relative abundance of bacteria within biofilms present in CVPs as identified by NGS, according to catheter dwell time.

Study contacts

Contact information is provided by the study sponsor or research team.

Maryline DELATTRE

CONTACT

[email protected]

+33130755031

Marylise ADECHIAN

CONTACT

[email protected]

+33130755069

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Collaborators

  • Université de Cergy Pontoise

Registry information

Acronym: KTBIO

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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