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Not yet recruiting NCT07546994

Biofilm-induced Antimicrobial Resistance RIsk ERadication in Critical Care Central Venous Catheters

Observational Catheter-Related Infections Biofilms Infection Prevention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Microbial analysis of catheter biofilm.
Who it may be relevant to
Registry conditions: Catheter-Related Infections, Biofilms, Infection Prevention. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Central venous catheter (CVC) infections are a frequent and serious nosocomial complication in critical care, leading to increased morbidity, mortality, and costs. The pathophysiology of these infections relies on the formation of a biofilm, an organized microbial structure that confers exceptional tolerance to anti-infectives and the immune system. However, data concerning the characteristics of the in vivo biofilm (kinetics, composition, endo- vs. extraluminal organization) on central venous catheters in intensive care patients are very limited, hindering the development of effective and targeted prevention strategies. The main aim of this study is to quantify the density and describe the spatial distribution (extra- and intraluminal compartments) of the biofilm on infected or colonized central venous catheters, prospectively collected from patients in the critical care units.

Interventions

  • Other Microbial analysis of catheter biofilm
    Identification and sampling of the catheter, standard microbiological analysis, inclusion and transfer (INSERM platform), biofilm analysis, and collection of associated data (clinical, biological and related to the catheter).

Primary outcome measures

  • Concentration (density) of viable bacterial biofilm [Time frame: Baseline]
Secondary outcome measures (3)
  • Provide a descriptive analysis of the population of colonized or infected central venous catheters, including clinical, biological, and microbiological data. [Time frame: Baseline]
  • Evaluate correlation between biofilm density and the following factors: microbiological, catheter-related, clinical, and patient-related. [Time frame: Baseline]
  • Evaluate correlation between the preferred location of biofilm and the following factors: microbiological, catheter-related, clinical, and patient-related. [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Central venous catheters (conventional central venous lines, dialysis catheters, PICC lines) showing positive microbiological culture taken from adult patients in the critical care units (intensive care units, post-operative intensive care units and post-resuscitation intensive care units)
  • Patient consent is free, informed, and non-opposition, provided after delivery of an information letter and oral explanation.

Exclusion criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • CH d'Alès — Alès
  • CHU de Nîmes — Nîmes

Identifiers

NCT: NCT07546994 · NIMAO/2025-2/BN-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗