BiofilmsOCT-BIO-KTANCT06838598
Structural and Microbiological Characterization of Arterial Catheter Biofilm in ICU's Patients Using Optical Coherence Tomography
An observational study of Biofilms and Arterial Catheterization, Peripheral, run by Centre Hospitalier William Morey - Chalon sur Saône at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biofilms, Arterial Catheterization, Peripheral, Bacteremia
- What is being tested?
- OCT-BIO-KTA cohort
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 3 Jun 2024to Dec 2027
- 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: Patient over 18 years of age with artherial catheter more than 2 calendar days
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Thomas MALDINEY contact
France2 sites, 2 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, Bourgogne-Franche-Comté, 21000
QUENOT Jean Pierre, MD-PhD, jean-pierre.quenot@chu-dijon.fr
- Recruiting
CH Macon
Mâcon, Bourgogne-Franche-Comté, 71000
MAILLET Thibault, MD, thmaillet@ch-macon.fr
About this study
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.
- Being tested
- OCT-BIO-KTA cohort
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-BIO-KTA cohortOther
Dynamic full-field optical coherence tomography (D-FF-OCT) analysis of arterial catheter sections before microbiological analysis of catheter biofilm
| Study group | Role | What they receive |
|---|---|---|
| OCT-BIO-KTA cohort | Critically ill patient > 18 years of age with artherial catheter for >2 calendar days in ICU Receives: Other: OCT-BIO-KTA cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Outcome measure is assessed 2 days following catheter removal
Secondary outcomes (3)
Bacterial or fungal indentification
Identification and enumeration of species - whether bacterial or fungal - by mass spectrometry from culture in agar medium of biofilm samples
Measured: Outcome measure is assessed 2 days following catheter removal
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
Measured: Outcome measure is assessed 2 days following catheter removal
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
Measured: Outcome measure is assessed 2 days following catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start3 Jun 2024
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiofilmsStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier William Morey - Chalon sur Saône
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon, Centre Hospitalier Macon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838598
- Sponsor's protocol ID
- OCT-BIO-KTA
- Acronym
- OCT-BIO-KTA
- Status last verified
- Mar 2026
- First submitted
- 21 Aug 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Microbiological Characterization of Arterial Catheter Biofilm in ICU's Patients Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT06838598
- Acronym / sponsor ID
- OCT-BIO-KTA / OCT-BIO-KTA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier William Morey - Chalon sur SaôneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon, Centre Hospitalier Macon
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Feb 2025 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT-BIO-KTA cohort | – | Other: OCT-BIO-KTA cohortCritically ill patient > 18 years of age with artherial catheter for >2 calendar days in ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient over 18 years of age with artherial catheter more than 2 calendar days
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| OCT-BIO-KTA cohortDynamic full-field optical coherence tomography (D-FF-OCT) analysis of arterial catheter sections before microbiological analysis of catheter biofilm | Other | OCT-BIO-KTA cohort |
Primary outcome
Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT
Time frame: Outcome measure is assessed 2 days following catheter removal
Provide a better understanding of the relation between structural and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT
3 secondary outcomes
Bacterial or fungal indentification
Time frame: Outcome measure is assessed 2 days following catheter removal
Biofilm thickness, measured with D-FF-OCT
Time frame: Outcome measure is assessed 2 days following catheter removal
Biofilm dynamic signal distribution, measured with D-FF-OCT
Time frame: Outcome measure is assessed 2 days following catheter removal
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 18 Mar 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.
Thomas MALDINEY contact
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 Biofilms and Arterial Catheterization, Peripheral, run by Centre Hospitalier William Morey - Chalon sur Saône 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Mar 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 Florian PERRAUD (06 78 58 85 19, florian.perraud@ch-chalon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT (time frame: Outcome measure is assessed 2 days following catheter removal). 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 18 Mar 2026.