Healthcare Associated InfectionOCT-BIO-CVCNCT06216080
Dynamic Full-Field Optical Coherence Tomography for Structural and Microbiological Characterization of Central Venous Catheter-deposited Biofilm in Critically Ill Patients
An observational study of Healthcare Associated Infection and Critically Ill, run by Centre Hospitalier William Morey - Chalon sur Saône at 1 site in France.
Trial summary
29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, with a significant proportion related to central venous catheters, and an influence on both morbility and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare Associated Infection, Critically Ill, Central Venous Catheter Associated Bloodstream Infection
- What is being tested?
- D-FF-OCT analysis of CVC
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2023to 10 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 having declared their nonobjection and exposed to central venous catheter for at least two calendar days
Who may be able to join
- Patient or relative informed of the study and having declared their nonobjection
- Patient over 18 years of age
- Patient exposed to central venous catheter for at least two calendar days
Who cannot join
- Patient unable to declare their nonobjection
- Patient whose central venous catheter collection is impossible
- Patient admitted in ICU with a central venous catheter already in place
Trial locations and contacts
1 site in 1 country.
France1 site
William Morey General Hospital (Chalon-sur-Saône)
Chalon-sur-Saône, Saône-et-Loire, 71100
About this study
29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, with a significant proportion related to central venous catheters, and an influence on both morbility and mortality.
It is now accepted that microbiological biofilm plays a key role on both bacterial and fungal 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.
We assume that a more precise characterization of central venous catheter-deposited biofilm could help us better understand invasive medical device-related healthcare infections in critically ill patients.
- Conditions
- Healthcare Associated Infection, Critically Ill, Central Venous Catheter Associated Bloodstream Infection
- Being tested
- D-FF-OCT analysis of CVC
- Medical subject headings
- Cross Infection, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-FF-OCT analysis of CVCOther
Dynamic full-field optical coherence tomography analysis of central venous catheter sections to better apprehend strucural characterization of central venous catheter-deposited biofilm
| Study group | Role | What they receive |
|---|---|---|
| OCT-BIO-CVC cohort | Adult critically ill patients (> 18 years of age) exposed to central venous catheter for at least two calendar days Receives: Other: D-FF-OCT analysis of CVC |
What is being measured
The primary outcome is the main question the study is designed to answer.
D-FF-OCT-based biofilm structure type
Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT
Measured: At Day 0, within 24h following catheter removal
Secondary outcomes (2)
D-FF-OCT-based biofilm thickness
Biofilm thickness, measured with D-FF-OCT
Measured: At Day 0, within 24h following catheter removal
D-FF-OCT-based dynamic signal distribution
Biofilm dynamic signal distribution, measured with D-FF-OCT
Measured: At Day 0, within 24h 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 posted22 Jan 2024
- Study start1 May 2023
- Primary completion30 Dec 2024
- Study completion10 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthcare Associated InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier William Morey - Chalon sur Saône
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Responsible party
- Sponsor
- Investigators
- Thomas Maldiney, Principal investigator, William Morey General Hospital (Chalon-sur-Saône)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216080
- Sponsor's protocol ID
- OCT-BIO-CVC
- Acronym
- OCT-BIO-CVC
- Status last verified
- Jan 2024
- First submitted
- 1 Jan 2024
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Perez-Granda MJ, Guembe M, Cruces R, Barrio JM, Bouza E. Assessment of central venous catheter colonization using surveillance culture of withdrawn connectors and insertion site skin. Crit Care. 2016 Feb 2;20:32. doi: 10.1186/s13054-016-1201-0.
PubMed 26838274Silva Paes Leme AF, Ferreira AS, Alves FA, de Azevedo BM, de Bretas LP, Farias RE, Oliveira MG, Raposo NR. An effective and biocompatible antibiofilm coating for central venous catheter. Can J Microbiol. 2015 May;61(5):357-65. doi: 10.1139/cjm-2014-0783. Epub 2015 Mar 2.
PubMed 25826042
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Full-Field Optical Coherence Tomography for Structural and Microbiological Characterization of Central Venous Catheter-deposited Biofilm in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06216080
- Acronym / sponsor ID
- OCT-BIO-CVC / OCT-BIO-CVC
- Conditions
- Healthcare Associated Infection, Critically Ill, Central Venous Catheter Associated Bloodstream Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier William Morey - Chalon sur SaôneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Dijon
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 10 Feb 2025 (actual)
- First posted
- 22 Jan 2024 (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, with a significant proportion related to central venous catheters, and an influence on both morbility and mortality.
It is now accepted that microbiological biofilm plays a key role on both bacterial and fungal 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.
We assume that a more precise characterization of central venous catheter-deposited biofilm could help us better understand invasive medical device-related healthcare infections in critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT-BIO-CVC cohort | – | Other: D-FF-OCT analysis of CVCAdult critically ill patients (> 18 years of age) exposed to central venous catheter for at least two calendar days |
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 having declared their nonobjection and exposed to central venous catheter for at least two calendar days
Key inclusion criteria (3 listed)
- Patient or relative informed of the study and having declared their nonobjection
- Patient over 18 years of age
- Patient exposed to central venous catheter for at least two calendar days
Key exclusion criteria (3 listed)
- Patient unable to declare their nonobjection
- Patient whose central venous catheter collection is impossible
- Patient admitted in ICU with a central venous 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 |
|---|---|---|
| D-FF-OCT analysis of CVCDynamic full-field optical coherence tomography analysis of central venous catheter sections to better apprehend strucural characterization of central venous catheter-deposited biofilm | Other | OCT-BIO-CVC cohort |
Primary outcome
D-FF-OCT-based biofilm structure type
Time frame: At Day 0, within 24h following catheter removal
Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT
2 secondary outcomes
D-FF-OCT-based biofilm thickness
Time frame: At Day 0, within 24h following catheter removal
D-FF-OCT-based dynamic signal distribution
Time frame: At Day 0, within 24h following catheter removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Background: PubMed 26838274Perez-Granda MJ, Guembe M, Cruces R, Barrio JM, Bouza E. Assessment of central venous catheter colonization using surveillance culture of withdrawn connectors and insertion site skin. Crit Care. 2016 Feb 2;20:32. doi: 10.1186/s13054-016-1201-0.
- Background: PubMed 25826042Silva Paes Leme AF, Ferreira AS, Alves FA, de Azevedo BM, de Bretas LP, Farias RE, Oliveira MG, Raposo NR. An effective and biocompatible antibiofilm coating for central venous catheter. Can J Microbiol. 2015 May;61(5):357-65. doi: 10.1139/cjm-2014-0783. Epub 2015 Mar 2.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Thomas Maldiney principal investigator
William Morey General Hospital (Chalon-sur-Saône)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthcare Associated Infection and Critically Ill, run by Centre Hospitalier William Morey - Chalon sur Saône at 1 site 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 3 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: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
D-FF-OCT-based biofilm structure type (time frame: At Day 0, within 24h following catheter removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06216080, which also lists 2 linked publications.
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 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.