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

NCT07546994 | Not Yet Recruiting

• 1 other identifier: NIMAO/2025-2/BN-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Catheter-Related Infections; Biofilms; Infection Prevention

Outcome Measures

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)

  Baseline

Secondary Outcomes (3)

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

  Baseline

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

  Baseline

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

  Baseline

Study Arms (1)

Patients with infected central venous catheters

Other: Microbial analysis of catheter biofilm

Interventions

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).

Patients with infected central venous catheters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CH d'Alès

Alès, France

Location

CHU de Nîmes

Nîmes, France

Location

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Nicolas Boulet

  Centre Hospitalier Universitaire de Nīmes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Boulet

CONTACT

+334 66 68 33 31; nicolas.boulet@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 23, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (2)