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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nīmes

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Microbial analysis of catheter biofilm

    Other intervention

    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).

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Patients with infected central venous catheters1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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