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NCT Number: NCT07546994

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

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.

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Key information

Conditions

Catheter-Related Infections Biofilms Infection Prevention Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH d'Alès, Alès, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microbial analysis of catheter biofilm

Other

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 outcomes

  1. Concentration (density) of viable bacterial biofilm

    Time frame: Baseline

    Measured in Colony Forming Units per millilitre (CFU/mL) for each compartment of the central venous catheter (internal and external lumen of the catheter)

Secondary outcomes

  1. Provide a descriptive analysis of the population of colonized or infected central venous catheters, including clinical, biological, and microbiological data.

    Time frame: 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.

  2. Evaluate correlation between biofilm density and the following factors: microbiological, catheter-related, clinical, and patient-related.

    Time frame: Baseline

    See previous description of the outcomes

  3. Evaluate correlation between the preferred location of biofilm and the following factors: microbiological, catheter-related, clinical, and patient-related.

    Time frame: Baseline

    See previous description of the outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas Boulet

CONTACT

[email protected]

+334 66 68 33 31

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: BARRIER

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 23, 2026
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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