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

• Conditions: Biofilm Formation; Structural and Microbiological Characterization of Endotracheal Tube Biofilm; Ventilator-associated Pneumonia (VAP)
• Interventions: Biological: microbiological characterization

• Registration Number: NCT04926493
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-05-01
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-06-08
• Last Update Submitted: 2021-06-08
• Study First Posted: 2021-06-15
• Last Update Posted: 2021-06-15
• Primary Completion: 2021-07
• Study Completion: 2021-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIOPAVIR Cohort	microbiological characterization	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.

Primary Outcome Measures

Name	Time	Method
Development of Ventilator-associated pneumonia (VAP)	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.

Secondary Outcome Measures

Name	Time	Method
Development of other VAP, healthcare-associated infection (HAI) or mortality	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 other VAP, healthcare-associated infection (HAI) or mortality in ICU during COVID-19 pandemic.

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France