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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Catheter-Related Infections; Infection Prevention; Biofilms
• Intervention / Treatment: Other: Microbial analysis of catheter biofilm

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Nicolas Boulet; Phone Number: +334 66 68 33 31; Email: nicolas.boulet@chu-nimes.fr

Study Locations

• France
  • Alès, France
    • CH d'Alès
    • Contact: Lucile Cadot; Phone Number: 04 66 78 31 42; Email: dr.cadot@ch-ales.fr
  • Nîmes, France
    • CHU de Nîmes
    • Contact: Anissa Megzari; Phone Number: 04.66.68.42.36; Email: drc@chu-nimes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All central venous catheters (conventional, dialysis catheters, or PICC lines) that test positive for microorganisms.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with infected central venous catheters	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration (density) of viable bacterial biofilm	Measured in Colony Forming Units per millilitre (CFU/mL) for each compartment of the central venous catheter (internal and external lumen of the catheter)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provide a descriptive analysis of the population of colonized or infected central venous catheters, including clinical, biological, and microbiological data.	Causative microorganism (categorical outcome); Catheter-related data (binary, numerical or categorical outcomes): catheter type, duration of catheterization (in days), time between admission and catheter placement (in days), insertion site, catheter rank; Type of infection (categorical outcome) : colonization, local infection, catheter-related sepsis, or catheter-related bacteremia; Associated conditions (binary or categorical outcomes): immunosuppression, diagnostic category, patient intubated or previously intubated (with overlap with the catheter being analyzed), patient on dialysis or previously on dialysis (with overlap with the catheter being analyzed), antibiotic therapy during the lifespan of the catheter being analyzed, parenteral nutrition during the lifespan of the catheter being analyzed.	Baseline
Evaluate correlation between biofilm density and the following factors: microbiological, catheter-related, clinical, and patient-related.	See previous description of the outcomes	Baseline
Evaluate correlation between the preferred location of biofilm and the following factors: microbiological, catheter-related, clinical, and patient-related.	See previous description of the outcomes	Baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Nicolas Boulet, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 23, 2026

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Catheter-Related Infections
• Other Study ID Numbers: NIMAO/2025-2/BN-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No