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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07546994
Acronym
BARRIER
Enrollment
150
Registered
2026-04-23
Start date
2026-04-01
Completion date
2028-04-01
Last updated
2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biofilms, Catheter-Related Infections, Infection Prevention

Brief summary

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

OTHERMicrobial 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).

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Concentration (density) of viable bacterial biofilmBaselineMeasured in Colony Forming Units per millilitre (CFU/mL) for each compartment of the central venous catheter (internal and external lumen of the catheter)

Secondary

MeasureTime frameDescription
Provide a descriptive analysis of the population of colonized or infected central venous catheters, including clinical, biological, and microbiological data.Baseline* 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.
Evaluate correlation between biofilm density and the following factors: microbiological, catheter-related, clinical, and patient-related.BaselineSee previous description of the outcomes
Evaluate correlation between the preferred location of biofilm and the following factors: microbiological, catheter-related, clinical, and patient-related.BaselineSee previous description of the outcomes

Countries

France

Contacts

CONTACTNicolas Boulet
nicolas.boulet@chu-nimes.fr+334 66 68 33 31
PRINCIPAL_INVESTIGATORNicolas Boulet

Centre Hospitalier Universitaire de Nīmes

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026