Biofilm FormationBIOPAVIRNCT04926493
Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit
An observational study of Biofilm Formation and Structural and Microbiological Characterization of Endotracheal Tube Biofilm, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Ventilator-associated pneumonia (VAP) remains the most frequent healthcare-associated infection (HAI) in the intensive care unit (ICU) and one of the most critical risk factors associated with both significant morbidity as well as mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biofilm Formation, Structural and Microbiological Characterization of Endotracheal Tube Biofilm, Ventilator-associated Pneumonia (VAP)
- What is being tested?
- microbiological characterization
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 31 Jul 2021
- 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 > 18 years of age with mechanical ventilation for >2 calendar days
Who may be able to join
- patient > 18 years of age with mechanical ventilation for >2 calendar days
Who cannot join
- inability to collect or dispatch the endotracheal tube for proper characterization within 24 hours post-extubation
Trial locations and contacts
1 site in 1 country.
About this study
Ventilator-associated pneumonia (VAP) remains the most frequent healthcare-associated infection (HAI) in the intensive care unit (ICU) and one of the most critical risk factors associated with both significant morbidity as well as mortality. Although VAP treatment relies on early and appropriate antimicrobial therapy, several preventive measures have been described in the literature in order to limit its incidence and clinical impact in the ICU. Among these, preventing biofilm formation on the inner surface of the endotracheal tube appears to hold promise. Yet there is a lack of clinical relevant data documenting a causal relation between biofilm formation and VAP. Designed to overcome this critical limitation, the BIOPAVIR study intends to provide a better structural and microbiological characterization of endotracheal tube biofilm in critically ill patients at increased risk for the development of VAP in ICU during COVID-19 pandemic.
- Conditions
- Biofilm Formation, Structural and Microbiological Characterization of Endotracheal Tube Biofilm, Ventilator-associated Pneumonia (VAP)
- Being tested
- microbiological characterization
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbiological characterizationBiological
microbiological characterization of endotracheal tube biofilm
| Study group | Role | What they receive |
|---|---|---|
| BIOPAVIR Cohort | Critically ill patient > 18 years of age with mechanical ventilation for >2 calendar days, at increased risk for the development of Ventilator-Associated Pneumonia in the Intensive Care Unit during COVID-19 pandemic. Receives: Biological: microbiological characterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Ventilator-associated pneumonia (VAP)
Provide a better understanding of the correlation between structural and microbiological characterization of endotracheal tube biofilm in critically ill patients and increased risk for the development of VAP in ICU during COVID-19 pandemic.
Measured: Immediately after extubation of the patient
Secondary outcomes (1)
Development of other VAP, healthcare-associated infection (HAI) or mortality
Provide a better understanding of the correlation between structural and microbiological characterization of endotracheal tube biofilm in critically ill patients and increased risk for the development of other VAP, healthcare-associated infection (HAI) or mortality in ICU during COVID-19 pandemic.
Measured: Immediately after extubation of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start1 May 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biofilm FormationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926493
- Sponsor's protocol ID
- QUENOT-Maldiney 2021
- Acronym
- BIOPAVIR
- Status last verified
- Jan 2026
- First submitted
- 27 May 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Maldiney T, Pineau V, Neuwirth C, Ouzen L, Eberl I, Jeudy G, Dalac S, Piroth L, Blot M, Sautour M, Dalle F, Abdulmalak C, Ter Schiphorst R, Pugliesi PS, Poussant T, Ogier-Desserrey A, Fournel I, de Giraud d'Agay M, Jacquier M, Labruyere M, Aptel F, Roudaut JB, Vieille T, Andreu P, Prin S, Charles PE, Hamet M, Quenot JP. Endotracheal tube biofilm in critically ill patients during the COVID-19 pandemic : description of an underestimated microbiological compartment. Sci Rep. 2022 Dec 27;12(1):22389. doi: 10.1038/s41598-022-26560-w.
PubMed 36575298
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04926493
- Acronym / sponsor ID
- BIOPAVIR / QUENOT-Maldiney 2021
- Conditions
- Biofilm Formation, Structural and Microbiological Characterization of Endotracheal Tube Biofilm, Ventilator-associated Pneumonia (VAP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 15 Jun 2021 (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.
Ventilator-associated pneumonia (VAP) remains the most frequent healthcare-associated infection (HAI) in the intensive care unit (ICU) and one of the most critical risk factors associated with both significant morbidity as well as mortality. Although VAP treatment relies on early and appropriate antimicrobial therapy, several preventive measures have been described in the literature in order to limit its incidence and clinical impact in the ICU. Among these, preventing biofilm formation on the inner surface of the endotracheal tube appears to hold promise. Yet there is a lack of clinical relevant data documenting a causal relation between biofilm formation and VAP. Designed to overcome this critical limitation, the BIOPAVIR study intends to provide a better structural and microbiological characterization of endotracheal tube biofilm in critically ill patients at increased risk for the development of VAP in ICU during COVID-19 pandemic.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIOPAVIR Cohort | – | Biological: microbiological characterizationCritically ill patient > 18 years of age with mechanical ventilation for >2 calendar days, at increased risk for the development of Ventilator-Associated Pneumonia in the Intensive Care Unit during COVID-19 pandemic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient > 18 years of age with mechanical ventilation for >2 calendar days
Key inclusion criteria (1 listed)
- patient > 18 years of age with mechanical ventilation for >2 calendar days
Key exclusion criteria (1 listed)
- inability to collect or dispatch the endotracheal tube for proper characterization within 24 hours post-extubation
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 |
|---|---|---|
| microbiological characterizationmicrobiological characterization of endotracheal tube biofilm | Biological | BIOPAVIR Cohort |
Primary outcome
Development of Ventilator-associated pneumonia (VAP)
Time frame: Immediately after extubation of the patient
Provide a better understanding of the correlation between structural and microbiological characterization of endotracheal tube biofilm in critically ill patients and increased risk for the development of VAP in ICU during COVID-19 pandemic.
1 secondary outcome
Development of other VAP, healthcare-associated infection (HAI) or mortality
Time frame: Immediately after extubation of the patient
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 3 Feb 2026.
- Results publication: PubMed 36575298Maldiney T, Pineau V, Neuwirth C, Ouzen L, Eberl I, Jeudy G, Dalac S, Piroth L, Blot M, Sautour M, Dalle F, Abdulmalak C, Ter Schiphorst R, Pugliesi PS, Poussant T, Ogier-Desserrey A, Fournel I, de Giraud d'Agay M, Jacquier M, Labruyere M, Aptel F, Roudaut JB, Vieille T, Andreu P, Prin S, Charles PE, Hamet M, Quenot JP. Endotracheal tube biofilm in critically ill patients during the COVID-19 pandemic : description of an underestimated microbiological compartment. Sci Rep. 2022 Dec 27;12(1):22389. doi: 10.1038/s41598-022-26560-w.
Related trials for Biofilm Formation
Not yet recruitingObservational study
Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus
Staphylococcal Aureus Infection, Surgical Site Infection (SSI)
Recruiting
Investigation of Biofilm Formation on Temporary push-on Rings of Implant Crowns
Dental Plaque, Oral Biofilm
Not yet recruiting
Development of Biofunctional 3D-Printed Orthodontic Aligners With Antimicrobial and Remineralizing Properties
Orthodontic Aligner Material, Enamel Demineralization
Not yet recruitingObservational study
Phenotypic and Genotypic Detection of Biofilm Formation and Efflux Pump Activity in Multi-drug Resistant Klebsiella Pneumoniae
Multidrug Resistant Klebsiella Pneumoniae Infection
Not yet recruitingObservational study
Antibiofilm Activity of Chitosan Nanoparticles Against Uropathogenic Escherichia Coli
Urinary Tract Infections (UTIs), Catheter-Associated Urinary Tract Infections (CAUTIs)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Biofilm Formation and Structural and Microbiological Characterization of Endotracheal Tube Biofilm, run by Centre Hospitalier Universitaire Dijon 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 1 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: finished, as of the sponsor's last update on 3 Feb 2026. 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?
Development of Ventilator-associated pneumonia (VAP) (time frame: Immediately after extubation of the patient). 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 NCT04926493, which also lists 1 linked publication.
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 3 Feb 2026.