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Clinical Trials/NCT04926493
NCT04926493
Completed
Not Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country61 target enrollmentMay 1, 2021

Overview

Phase
Not Applicable
Intervention
microbiological characterization
Conditions
Biofilm Formation
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
61
Locations
1
Primary Endpoint
Development of Ventilator-associated pneumonia (VAP)
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2021
End Date
July 31, 2021
Last Updated
2 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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.

Intervention: microbiological characterization

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Development of other VAP, healthcare-associated infection (HAI) or mortality(Immediately after extubation of the patient)

Study Sites (1)

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