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Not yet recruitingNCT07546994BARRIERUpdated Apr 23, 2026

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

An observational study in Catheter-Related Infections, Biofilms and Infection Prevention, sponsored by Centre Hospitalier Universitaire de Nīmes. Not yet recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Catheter-Related Infections
  • Biofilms
  • Infection Prevention
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In context

Catheter-Related Infections

107 studies on the registry are indexed under Catheter-Related Infections; 16 are open to participants now.

This study's planned enrollment of 150 is below the median of 200 across 25 observational studies indexed under Catheter-Related Infections.

Browse Catheter-Related Infections studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with infected central venous catheters

    Other: Microbial analysis of catheter biofilm

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).

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline

Secondary outcomes

  1. 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.

    Time frame: Baseline

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

    See previous description of the outcomes

    Time frame: Baseline

  3. 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

    Time frame: Baseline

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Study locations

2 sites
  • CH d'Alès
    Alès, France
  • CHU de Nîmes
    Nîmes, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07546994
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Apr 23, 2026
Start date
Apr 2026 (estimated)
Primary completion
Apr 2028 (estimated)
Completion
Apr 2028 (estimated)
Last update
Apr 23, 2026

Study contacts

Nicolas Boulet
Contact
nicolas.boulet@chu-nimes.fr
+334 66 68 33 31
Nicolas Boulet
principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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