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

Ventilator-associated Pneumonia (VAP) Clinical Trial

— BIOPAVIR  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04926493
• Other study ID #: QUENOT-Maldiney 2021
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: July 2021

Study information

• Verified date: May 2021
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Jean Pierre QUENOT
• Phone: 03.80.29.36.85
• Email: jean-pierre.quenot[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 61
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biofilm Formation
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator-associated Pneumonia (VAP)

Intervention

Biological:
• microbiological characterization
microbiological characterization of endotracheal tube biofilm

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Immediately after extubation of the patient