Healthcare Associated InfectionBIOPAVIR2NCT06379139
Dynamic Full-field Optical Coherence Tomography for Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Critically Ill Patients
An observational study of Healthcare Associated Infection and Critically Ill, run by Centre Hospitalier Universitaire Dijon at 2 sites in France.
Trial summary
Biofilm is a microstructure organised into aggregates of microbiological species within a polymeric matrix. As early as the 2000s, the Centers for Disease Control and Prevention (CDC) recognised the possible role of the biofilm lining endotracheal endotracheal tubes in the development of ventilator-associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthcare Associated Infection, Critically Ill, Endotracheal Tube
- What is being tested?
- •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tube
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2024to Mar 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 mechanical ventilation 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 mechanical ventilation for at least two calendar days
Who cannot join
- Patient unable to declare their nonobjection
- Patient whose endotracheal tube collection is impossible
- Patient whose endotracheal tube is collected following self-extubation (sample contamination)
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
CH William Morey
Chalon-sur-Saône
Thomas MALDINEY, thomas.maldiney@ch-chalon71.fr
- Recruiting
CHU Dijon Bourgogne
Dijon
Jean Pierre QUENOT, jean-pierre.quenot@chu-dijon.fr
About this study
Official title: Dynamic Full-field Optical Coherence Tomography for Endotracheal Tube Biofilm Characterization in Critically Ill Patients
Biofilm is a microstructure organised into aggregates of microbiological species within a polymeric matrix. As early as the 2000s, the Centers for Disease Control and Prevention (CDC) recognised the possible role of the biofilm lining endotracheal endotracheal tubes in the development of ventilator-associated pneumonia (VAP) , the most common infection in intensive care, with a high morbidity and mortality rate and a significant increase in hospital costs.
Targeting biofilm therefore now appears to be a new area of interest for limiting the risk of VAP, and this rationale has led to the development of an intraluminal for abrading biofilm deposited on the inside of the intubation probe
Read more
. Evaluation of this type of strategy nevertheless justifies the introduction of more precise methods for characterisation of the biofilm.
To this end, the investigator carried out an initial clinical study describing the biofilm on intubation probes, BIOPAVIR 1, showing the existence of several biofilm structures, each associated with a specific microbiological signature. Several limitations including a lack of power due to an insufficient number of patients and the use of number of patients, and the use of a confocal microscopy technique with poor axial without the possibility of acquiring metabolic images of the biofilm.
Based on the previous description of biofilm by optical coherence tomography (OCT), and a recent experience with an optimised form of high-resolution OCT, called full-field OCT, the investigator hypothesise that full-field OCT will allow more accurate characterisation of biofilm, due to its high spatial resolution and its potential ability to capture metabolic activity in the biofilm BIOPAVIR 2 proposes to use the performance of full-field OCT to better characterise the biofilm lining endotracheal tubes in patients undergoing mechanical ventilation in intensive care units. This project represents a first step towards understanding the link between the development of biofilm on intubation and the occurrence of VAP
- Being tested
- •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tube
- 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.
•Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tubeOther
Dynamic full-field optical coherence tomography analysis of endotracheal tube sections to better apprehend strucural characterization of endotracheal tube-deposited biofilm
| Study group | Role | What they receive |
|---|---|---|
| BIOPAVIR 2 cohort | Adult critically ill patients (> 18 years of age) exposed to endotracheal tube for at least two calendar days Receives: Other: •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Full-Field Optical Coherence Tomography-based biofilm structure type
shape data
Measured: At Day 0, within 72hours following endothracheal tube removal
type of microbiological associated with each shape
Measured: At Day 0, within 72hours following endothracheal tube removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Mar 2024
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas MALDINEY, Principal investigator, CH William Morey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379139
- Sponsor's protocol ID
- MALDINEY J'InvEst-I 2022
- Acronym
- BIOPAVIR2
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 23 Apr 2024
- 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 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Full-field Optical Coherence Tomography for Endotracheal Tube Biofilm Characterization in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06379139
- Acronym / sponsor ID
- BIOPAVIR2 / MALDINEY J'InvEst-I 2022
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 23 Apr 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.
Biofilm is a microstructure organised into aggregates of microbiological species within a polymeric matrix. As early as the 2000s, the Centers for Disease Control and Prevention (CDC) recognised the possible role of the biofilm lining endotracheal endotracheal tubes in the development of ventilator-associated pneumonia (VAP) , the most common infection in intensive care, with a high morbidity and mortality rate and a significant increase in hospital costs.
Targeting biofilm therefore now appears to be a new area of interest for limiting the risk of VAP, and this rationale has led to the development of an intraluminal for abrading biofilm deposited on the inside of the intubation probe
. Evaluation of this type of strategy nevertheless justifies the introduction of more precise methods for characterisation of the biofilm.
To this end, the investigator carried out an initial clinical study describing the biofilm on intubation probes, BIOPAVIR 1, showing the existence of several biofilm structures, each associated with a specific microbiological signature. Several limitations including a lack of power due to an insufficient number of patients and the use of number of patients, and the use of a confocal microscopy technique with poor axial without the possibility of acquiring metabolic images of the biofilm.
Based on the previous description of biofilm by optical coherence tomography (OCT), and a recent experience with an optimised form of high-resolution OCT, called full-field OCT, the investigator hypothesise that full-field OCT will allow more accurate characterisation of biofilm, due to its high spatial resolution and its potential ability to capture metabolic activity in the biofilm BIOPAVIR 2 proposes to use the performance of full-field OCT to better characterise the biofilm lining endotracheal tubes in patients undergoing mechanical ventilation in intensive care units. This project represents a first step towards understanding the link between the development of biofilm on intubation and the occurrence of VAP
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIOPAVIR 2 cohort | – | Other: •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tubeAdult critically ill patients (> 18 years of age) exposed to endotracheal tube 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 mechanical ventilation 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 mechanical ventilation for at least two calendar days
Key exclusion criteria (3 listed)
- Patient unable to declare their nonobjection
- Patient whose endotracheal tube collection is impossible
- Patient whose endotracheal tube is collected following self-extubation (sample contamination)
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 |
|---|---|---|
| •Dynamic Full-Field Optical Coherence Tomography analysis of endotracheal tubeDynamic full-field optical coherence tomography analysis of endotracheal tube sections to better apprehend strucural characterization of endotracheal tube-deposited biofilm | Other | BIOPAVIR 2 cohort |
Primary outcome
Dynamic Full-Field Optical Coherence Tomography-based biofilm structure type
Time frame: At Day 0, within 72hours following endothracheal tube removal
shape data
type of microbiological associated with each shape
Time frame: At Day 0, within 72hours following endothracheal tube removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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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
CH William Morey
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 Healthcare Associated Infection and Critically Ill, run by Centre Hospitalier Universitaire Dijon 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 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: status not confirmed, as of the sponsor's last update on 23 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas MALDINEY (385910474 ext. +33, thomas.maldiney@ch-chalon71.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Full-Field Optical Coherence Tomography-based biofilm structure type (time frame: At Day 0, within 72hours following endothracheal tube removal). The study lists 2 primary outcomes in all. 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 2024.