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VITAL - VAP Prevention by BIP (Bactiguard Infection Protection) ETT Evac in Belgian ICUs (VITAL)

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ClinicalTrials.gov Identifier: NCT04242706
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Bactiguard AB

Brief Summary:
The study objective is to determine VAP (Ventilator Associated Pneumonia) baseline incidence in the ICU in patients receiving endotracheal tubes with evacuation lumen with and without Bactiguard coating. The study is randomized, prospective, controlled and blinded. All adult 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.

Condition or disease Intervention/treatment Phase
Ventilator-associated Pneumonia Device: ETTEvac Device: BIP ETTEvac Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Controlled study. Two interventions:

  1. Endotracheal tube with evacuation lumen without Bactiguard coating.
  2. Endotracheal tube with evacuation lumen with Bactiguard coating.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinded, the two devices have the same appearance.
Primary Purpose: Prevention
Official Title: VITAL - VAP Prevention in ICU by BACTIGUARD coAting of endotracheaL Tube
Actual Study Start Date : November 5, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Control group
Endotracheal tube with evacuation lumen without Bactiguard coating.
Device: ETTEvac
Endotracheal tube with evacuation lumen without noble metal coating

Experimental: Experimental group
Endotracheal tube with evacuation lumen with Bactiguard coating.
Device: BIP ETTEvac
Endotracheal tube with evacuation lumen with noble metal coating




Primary Outcome Measures :
  1. VAP incidence [ Time Frame: Up to 28 days after inclusion ]
    Ventilator Associated Pneumonia incidence


Secondary Outcome Measures :
  1. Nosocomial infections [ Time Frame: Up to 28 days after inclusion ]
    Incidence of any kind of nosocomial infection

  2. VAT incidence [ Time Frame: Up to 28 days after inclusion ]
    Ventilator Associated Tracheabronchitis incidence

  3. Antibiotics consumption [ Time Frame: Up to 28 days after inclusion ]
  4. Duration of ventilation [ Time Frame: Up to 28 days after inclusion ]
    Days of intubation with study tube

  5. Duration of ICU and hospital stay [ Time Frame: Up to 28 days after inclusion ]
  6. Mortality [ Time Frame: Up to 60 days after inclusion ]
  7. Tracheal bacterial colonization [ Time Frame: Up to 28 days after inclusion ]
    Incidence of tracheal bacterial colonization reaching a CFU Count 10^6 CFU/ml

  8. VAC and iVAC [ Time Frame: Up to 28 days after inclusion ]
    Ventilator associated Condition and infectious iVAC


Other Outcome Measures:
  1. Evaluation of microbial data [ Time Frame: Up to 28 days of intubation after inclusion ]
    Amount and type of bacteria, resistance pattern

  2. Evaluation of durability of the coating metals at the surface during use [ Time Frame: Up to 28 days of intubation after inclusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242706


Contacts
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Contact: Benoît Misset, MD,Prof. +32-4-366 74 95 benoit.misset@chuliege.be
Contact: Pierre Damas, MD,Prof. +32-485-38 00 93 pdamas@chuliege.be

Locations
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Belgium
Centre Hospitalier Chrétien de Liège and Centre Hospitalier Chrétien (CHC Clinique de l'Espérance) Recruiting
Liege, Belgium
Contact: Philippe Devos, MD    04 224 81 11 ext +32    philippe.devos@chc.be   
Centre Hospitalier Universitaire Sart Tilman Liège Recruiting
Liège, Belgium, B-4000
Contact: Benoît Misset, MD, Prof    04-366 74 95 ext +32    benoit.misset@chuliege.be   
Contact: Pierre Damas    04-85-38 00 93 ext +32    pdamas@chuliege.be   
Sponsors and Collaborators
Bactiguard AB
Investigators
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Principal Investigator: Benoit Misset, MD,Prof. CHU, Liege; Belgium
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Responsible Party: Bactiguard AB
ClinicalTrials.gov Identifier: NCT04242706    
Other Study ID Numbers: PL-13674
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection