ClinicalTrials.gg
RecruitingNCT06838598OCT-BIO-KTAUpdated Mar 18, 2026

Structural and Microbiological Characterization of Arterial Catheter Biofilm in ICU's Patients Using Optical Coherence Tomography

An observational study in Biofilms, Arterial Catheterization, Peripheral and Bacteremia, sponsored by Centre Hospitalier William Morey - Chalon sur Saône. Recruiting at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Centre Hospitalier William Morey - Chalon sur Saône · Observational

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, including 7.7% to arterial catheters, with an influence on both morbility and mortality.

It is now accepted that biofilm as a role on bacterial development on inner surface of vascular devices but there is yet a lack of clinical relevant data documenting a causal relation between biofilm formation and bacteremias.

The investigators assume that a better structural and microbiological characterization of arterial catheter biofilm in ICU patients could help preventing bacteremias or have a more specific treatment when it appears.

02

Conditions studied

  • Biofilms
  • Arterial Catheterization, Peripheral
  • Bacteremia
  • Tomography, Optical Coherence

Browse trials for

03

In context

Bacteremia

297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.

This study's planned enrollment of 60 is below the median of 300 across 125 observational studies indexed under Bacteremia.

Browse Bacteremia studies →

Lead sponsor

Centre Hospitalier William Morey - Chalon sur Saône is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient over 18 years of age with artherial catheter more than 2 calendar days

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient or relative informed of the study and having declared their non-objection
  • Patient over 18 years old
  • Patient hospitalized in ICU with an arterial catheter

Exclusion criteria

Exclusion Criteria:

  • Patient unable to express consent
  • Patient whose collection of the arterial catheter is impossible or for whom storage at 4°C is impossible
  • Patient with arterial catheter removed outside the usual procedure of the ICU
  • Patient admitted in ICU with an arterial catheter already in place
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • OCT-BIO-KTA cohort

    Critically ill patient \> 18 years of age with artherial catheter for \>2 calendar days in ICU

    Other: OCT-BIO-KTA cohort

Interventions

  • OtherOCT-BIO-KTA cohort

    Dynamic full-field optical coherence tomography (D-FF-OCT) analysis of arterial catheter sections before microbiological analysis of catheter biofilm

06

What researchers measure

Primary outcomes

  1. Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT

    Provide a better understanding of the relation between structural and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT

    Time frame: Outcome measure is assessed 2 days following catheter removal

Secondary outcomes

  1. Bacterial or fungal indentification

    Identification and enumeration of species - whether bacterial or fungal - by mass spectrometry from culture in agar medium of biofilm samples

    Time frame: Outcome measure is assessed 2 days following catheter removal

  2. Biofilm thickness, measured with D-FF-OCT

    Provide a better understanding of the relation between thickness and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT

    Time frame: Outcome measure is assessed 2 days following catheter removal

  3. Biofilm dynamic signal distribution, measured with D-FF-OCT

    Provide a better understanding of the relation between dynamic signal distribution and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT

    Time frame: Outcome measure is assessed 2 days following catheter removal

07

Study locations

2 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06838598
Lead sponsor
Centre Hospitalier William Morey - Chalon sur Saône
Collaborators
Centre Hospitalier Universitaire Dijon, Centre Hospitalier Macon
Responsible party
Sponsor
First posted
Feb 20, 2025
Start date
Jun 3, 2024
Primary completion
Nov 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Mar 18, 2026

Study contacts

Florian PERRAUD
Contact
florian.perraud@ch-chalon.fr
06 78 58 85 19
Thomas MALDINEY
Contact
thomas.maldiney@ch-chalon.fr

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion