- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04242706
VITAL - VAP Prevention by BIP (Bactiguard Infection Protection) ETT Evac in Belgian ICUs (VITAL)
VITAL - VAP Prevention in ICU by BACTIGUARD coAting of endotracheaL Tube
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of the study is to determine VAP (Ventilator Associated Pneumonia) baseline incidence in the ICU in patients receiving endotracheal tubes with evacuation lumen with and without Bactiguard Infection Protection (BIP) coating.
VAP is likely to occur in 10-20% of patients who are ventilated for at least 48 hours. These patients face a mortality risk estimated to be twice as high compared with similar ICU patients without VAP. Furthermore, VAP results in an average excess length of ICU stay with high hospital cost.
Bactiguard has developed an endotracheal tube coated with a thin layer of non-releasing metals (gold, silver and palladium) firmly attached to the surface. This Bactiguard coating is tissue friendly and aims to achieve an optimal combination of anti-infective properties to reduce biofilm formation, colonization and subsequent respiratory infection. Bactiguard coated urinary products have been on market since 1995 (initially in US, then also in Japan & Europe) and used in a large number of clinical studies and evaluations, showing reduction of urinary tract infections and also antibiotics use. A BIP ETT (without evacuation lumen) clinical safety and tolerability study was performed at Karolinska University Hospital during 20128. The study showed that BIP ETT is safe, well tolerable and performs well in clinical settings.
The present study of BIP ETT with evacuation lumen is randomized, prospective, controlled and blinded. All adult ICU patients hospitalized in the ICUs from two tertiary hospitals (i.e.: Centre Hospitalier Universitaire Sart Tilman Liège , Centre Hospitalier Chrétien de Liège) and considered to be ventilated for more than 24 hours will be eligible to participate in the study. 300 patients in total will be used to determine baselines levels (150 in each group).
The study tubes will be available not only in the ICUs but also in the emergency department, including the emergency vehicles, and in every hospital wards. The study tubes will not be available in the operating rooms except in the Post Anesthesia Care Units (PACU) and Recovery rooms.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Liege, Belgium
- Centre Hospitalier Chrétien de Liège and Centre Hospitalier Chrétien (CHC Clinique de l'Espérance)
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Liège, Belgium, B-4000
- Centre Hospitalier Universitaire Sart Tilman Liège
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- intubation with a study tube and a presumed duration of ventilation for more than 24h,
- age > 18 y,
- signed informed consent
Exclusion Criteria:
- tracheostomized patient
- life expectancy less than 48h,
- previous participation in the study
- pregnant women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control group
Endotracheal tube with evacuation lumen without Bactiguard coating.
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Endotracheal tube with evacuation lumen without noble metal coating
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Experimental: Experimental group
Endotracheal tube with evacuation lumen with Bactiguard coating.
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Endotracheal tube with evacuation lumen with noble metal coating
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAP incidence
Time Frame: Up to 28 days after inclusion
|
Ventilator Associated Pneumonia incidence
|
Up to 28 days after inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nosocomial infections
Time Frame: Up to 28 days after inclusion
|
Incidence of any kind of nosocomial infection
|
Up to 28 days after inclusion
|
VAT incidence
Time Frame: Up to 28 days after inclusion
|
Ventilator Associated Tracheabronchitis incidence
|
Up to 28 days after inclusion
|
Antibiotics consumption
Time Frame: Up to 28 days after inclusion
|
Up to 28 days after inclusion
|
|
Duration of ventilation
Time Frame: Up to 28 days after inclusion
|
Days of intubation with study tube
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Up to 28 days after inclusion
|
Duration of ICU and hospital stay
Time Frame: Up to 28 days after inclusion
|
Up to 28 days after inclusion
|
|
Mortality
Time Frame: Up to 60 days after inclusion
|
Up to 60 days after inclusion
|
|
Tracheal bacterial colonization
Time Frame: Up to 28 days after inclusion
|
Incidence of tracheal bacterial colonization reaching a CFU Count 10^6 CFU/ml
|
Up to 28 days after inclusion
|
VAC and iVAC
Time Frame: Up to 28 days after inclusion
|
Ventilator associated Condition and infectious iVAC
|
Up to 28 days after inclusion
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of microbial data
Time Frame: Up to 28 days of intubation after inclusion
|
Amount and type of bacteria, resistance pattern
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Up to 28 days of intubation after inclusion
|
Evaluation of durability of the coating metals at the surface during use
Time Frame: Up to 28 days of intubation after inclusion
|
Up to 28 days of intubation after inclusion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benoit Misset, MD,Prof., CHU, Liege; Belgium
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PL-13674
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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