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OpenTrials
Completed

NCT Number: NCT04926493

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) 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microbiological characterization

Biological

microbiological characterization of endotracheal tube biofilm

Primary outcomes

  1. 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

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

    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 other VAP, healthcare-associated infection (HAI) or mortality in ICU during COVID-19 pandemic.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: BIOPAVIR

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2021
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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