Catheter-Related InfectionsBARRIERNCT07546994
Biofilm-induced Antimicrobial Resistance RIsk ERadication in Critical Care Central Venous Catheters
An observational study of Catheter-Related Infections and Biofilms, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections, Biofilms, Infection Prevention
- What is being tested?
- Microbial analysis of catheter biofilm
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2026to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All central venous catheters (conventional, dialysis catheters, or PICC lines) that test positive for microorganisms.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
CH d'Alès
Alès
Lucile Cadot, 04 66 78 31 42, dr.cadot@ch-ales.fr
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
About this study
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
- Being tested
- Microbial analysis of catheter biofilm
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbial analysis of catheter biofilmOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients with infected central venous catheters | Not described Receives: Other: Microbial analysis of catheter biofilm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Secondary outcomes (3)
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.
Measured: Baseline
Evaluate correlation between biofilm density and the following factors: microbiological, catheter-related, clinical, and patient-related.
See previous description of the outcomes
Measured: Baseline
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas Boulet, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546994
- Sponsor's protocol ID
- NIMAO/2025-2/BN-01
- Acronym
- BARRIER
- Status last verified
- Apr 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofilm-induced Antimicrobial Resistance RIsk ERadication in Critical Care Central Venous Catheters
- ClinicalTrials.gov ID
- NCT07546994
- Acronym / sponsor ID
- BARRIER / NIMAO/2025-2/BN-01
- Conditions
- Catheter-Related Infections, Biofilms, Infection Prevention
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with infected central venous catheters | – | Other: Microbial analysis of catheter biofilm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All central venous catheters (conventional, dialysis catheters, or PICC lines) that test positive for microorganisms.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbial analysis of catheter biofilmIdentification 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). | Other | Patients with infected central venous catheters |
Primary outcome
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)
3 secondary outcomes
Provide a descriptive analysis of the population of colonized or infected central venous catheters, including clinical, biological, and microbiological data.
Time frame: Baseline
Evaluate correlation between biofilm density and the following factors: microbiological, catheter-related, clinical, and patient-related.
Time frame: Baseline
Evaluate correlation between the preferred location of biofilm and the following factors: microbiological, catheter-related, clinical, and patient-related.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicolas Boulet principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Catheter-Related Infections and Biofilms, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Boulet (+334 66 68 33 31, nicolas.boulet@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration (density) of viable bacterial biofilm (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.