Catheter-Related InfectionsKTBIONCT07258862
Analysis of Microbial Biofilms in Peripheral Venous Catheters and Their Implication in Infectious Risk
An observational study of Catheter-Related Infections, run by Hôpital NOVO at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections
- What is being tested?
- Inflammatory catheters: catheter removed because of infection at insertion site and Non-inflammatory catheters: catheter removed because it is no longer relevant to keep it in place
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 250 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2026to 28 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient hospitalized in a care unit of the NOVO hospital
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Hopital Novo
Cergy-Pontoise, Hopital NOVO, 95303
Maryline DELATTRE, +33130754131, promotion-usrc@ght-novo.fr
DELATTRE
CY Cergy Paris Université
Neuville-sur-Oise
SEYER Damien, Phd, +33 1 34 25 66 96, damien.seyer@cyu.fr
About this study
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.
Read the 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
- Being tested
- 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
- Keywords
- Vascular Access Devices, Peripheral Venous Catheter, Catheter-Related Infections, Biofilms, Molecular Biology, Next-Generation Sequencing, Scanning Electron Microscopy
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inflammatory catheters: catheter removed because of infection at insertion siteDiagnostic 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 placeDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory catheters | Catheter removed because of infection at insertion site Receives: Diagnostic Test: 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 Receives: Device: Non-inflammatory catheters: catheter removed because it is no longer relevant to keep it in place |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 months
Secondary outcomes (3)
Biofilms structural morphology in PVCs
Qualitative imaging of microbial biofilms in PVCs using Scanning Electron Microscopy
Measured: 15 months
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
Measured: 15 months
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.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion28 Mar 2027 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Cergy Pontoise
- Responsible party
- Sponsor
- Investigators
- LECURU Marion, Doctor, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258862
- Sponsor's protocol ID
- CHRD1025
- Other IDs
- 202509 - 011
- Acronym
- KTBIO
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Microbial Biofilms in Peripheral Venous Catheters and Their Implication in Infectious Risk
- ClinicalTrials.gov ID
- NCT07258862
- Acronym / sponsor ID
- KTBIO / CHRD1025
- Conditions
- Catheter-Related Infections
- Keywords
- Vascular Access Devices, Peripheral Venous Catheter, Catheter-Related Infections, Biofilms, Molecular Biology, Next-Generation Sequencing, Scanning Electron Microscopy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Collaborators
- Université de Cergy Pontoise
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory catheters | – | Diagnostic Test: Inflammatory catheters: catheter removed because of infection at insertion siteCatheter removed because of infection at insertion site |
| Non-inflammatory catheters | – | Device: Non-inflammatory catheters: catheter removed because it is no longer relevant to keep it in placecatheter removed because it is no longer relevant to keep it in place |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient hospitalized in a care unit of the NOVO hospital
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inflammatory catheters: catheter removed because of infection at insertion siteVerification 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 | Diagnostic test | Inflammatory catheters |
| Non-inflammatory catheters: catheter removed because it is no longer relevant to keep it in placeVerification 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 |
Primary outcome
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.
3 secondary outcomes
Biofilms structural morphology in PVCs
Time frame: 15 months
Bacterial diversity of biofilms in PVCs according to type of substances administered through the vascular route
Time frame: 15 months
Bacterial diversity of biofilms in PVCs according to catheter dwell time
Time frame: 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LECURU Marion, Doctor principal investigator
Hôpital NOVO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter-Related Infections, run by Hôpital NOVO at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryline DELATTRE (+33130755031, maryline.delattre@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial diversity of biofilms in PVCs according to inflammatory symptoms (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.