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

NCT04926493 | Completed

• 1 other identifier: QUENOT-Maldiney 2021
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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. 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; Ventilator-associated Pneumonia (VAP); Structural and Microbiological Characterization of Endotracheal Tube Biofilm

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after extubation of the patient

Secondary Outcomes (1)

• Development of other VAP, healthcare-associated infection (HAI) or mortality

  Immediately after extubation of the patient

Study Arms (1)

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.

Biological: microbiological characterization

Interventions

microbiological characterization BIOLOGICAL

microbiological characterization of endotracheal tube biofilm

BIOPAVIR Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient \> 18 years of age with mechanical ventilation for \>2 calendar days

You may qualify if:

• patient \> 18 years of age with mechanical ventilation for \>2 calendar days

You may not qualify if:

• inability to collect or dispatch the endotracheal tube for proper characterization within 24 hours post-extubation

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

• 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.

  PMID: 36575298 RESULT

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 15, 2021
• Study Start: May 1, 2021
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

FR (1)