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De klinische studie NCT07258862 (KTBIO) voor Kathetergerelateerde infecties is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Analysis of Microbial Biofilms in Peripheral Venous Catheters and Their Implication in Infectious Risk (KTBIO)
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De klinische studie NCT07258862 (KTBIO) is een observationeel studie bij Kathetergerelateerde infecties met de status nog niet rekruterend. De inclusie van 250 deelnemers start op 1 januari 2026. De studie wordt geleid door Hôpital NOVO en de voltooiing is gepland op 28 maart 2027. Laatste update op ClinicalTrials.gov: 2 december 2025.
Beknopte samenvatting
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.
Uitgebreide beschrijving
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.
Officiële titel
Analysis of Microbial Biofilms in Peripheral Venous Catheters and Their Implication in Infectious Risk
Aandoeningen
Kathetergerelateerde infectiesAndere studie-ID's
- KTBIO
- CHRD1025
- 202509 - 011 (Overige identificatiecode) (Université Cergy Pontoise)
NCT-ID
Startdatum (Werkelijk)
2026-01-01
Laatste update geplaatst
2025-12-02
Verwachte einddatum
2027-03-28
Inschrijving (Geschat)
250
Studietype
Observationeel
Status
Nog niet rekruterend
Trefwoorden
Vascular Access Devices
Peripheral Venous Catheter
Catheter-Related Infections
Biofilms
Molecular Biology
Next-Generation Sequencing
Scanning Electron Microscopy
Peripheral Venous Catheter
Catheter-Related Infections
Biofilms
Molecular Biology
Next-Generation Sequencing
Scanning Electron Microscopy
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
Inflammatory catheters Catheter removed because of infection at insertion site | Inflammatory 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 |
Non-inflammatory catheters catheter removed because it is no longer relevant to keep it in place | Non-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 |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
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 |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Biofilms structural morphology in PVCs | Qualitative imaging of microbial biofilms in PVCs using Scanning Electron Microscopy | 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 | 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. | 15 months |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
- 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
- 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
Hôpital NOVOUniversité de Cergy PontoiseCentraal Contactpersoon
Contact: Maryline DELATTRE, +33130755031, [email protected]
Contact: Marylise ADECHIAN, +33130755069, [email protected]
2 Studielocaties in 1 landen
Hopital NOVO
Hopital Novo, Cergy-Pontoise, Hopital NOVO, 95303, France
Maryline DELATTRE, Contact, +33130754131, [email protected]
DELATTRE, Contact
CY Cergy Paris Université, Neuville-sur-Oise, France
SEYER Damien, Phd, Contact, +33 1 34 25 66 96, [email protected]