Ventilator-associated PneumoniaPhase 4VITALNCT04242706
VITAL - VAP Prevention by BIP (Bactiguard Infection Protection) ETT Evac in Belgian ICUs
A Phase 4 study testing ETTEvac and BIP ETTEvac in people with Ventilator-associated Pneumonia, run by Bactiguard AB at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Pneumonia
- What is being tested?
- ETTEvac and BIP ETTEvac
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 2 sitesBelgium
- Study dates
- 31 Oct 2018to 8 May 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- intubation with a study tube and a presumed duration of ventilation for more than 24h,
- age > 18 y,
- signed informed consent
Who cannot join
- tracheostomized patient
- life expectancy less than 48h,
- previous participation in the study
- pregnant women.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Centre Hospitalier Universitaire Sart Tilman Liège
Liège, B-4000
Centre Hospitalier Chrétien de Liège and Centre Hospitalier Chrétien (CHC Clinique de l'Espérance)
Liège
About this study
Official title: VITAL - VAP Prevention in ICU by BACTIGUARD coAting of endotracheaL Tube
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.
Read the 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.
- Conditions
- Ventilator-associated Pneumonia
- Being tested
- ETTEvac, BIP ETTEvac
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETTEvacDevice
Endotracheal tube with evacuation lumen without noble metal coating
BIP ETTEvacDevice
Endotracheal tube with evacuation lumen with noble metal coating
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Endotracheal tube with evacuation lumen without Bactiguard coating. Receives: Device: ETTEvac |
| Experimental group | Experimental | Endotracheal tube with evacuation lumen with Bactiguard coating. Receives: Device: BIP ETTEvac |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP incidence
Ventilator Associated Pneumonia incidence
Measured: Up to 28 days after inclusion
Secondary outcomes (8)
Nosocomial infections
Incidence of any kind of nosocomial infection
Measured: Up to 28 days after inclusion
VAT incidence
Ventilator Associated Tracheabronchitis incidence
Measured: Up to 28 days after inclusion
Antibiotics consumption
Measured: Up to 28 days after inclusion
Duration of ventilation
Days of intubation with study tube
Measured: Up to 28 days after inclusion
Duration of ICU and hospital stay
Measured: Up to 28 days after inclusion
Mortality
Measured: Up to 60 days after inclusion
Tracheal bacterial colonization
Incidence of tracheal bacterial colonization reaching a CFU Count 10^6 CFU/ml
Measured: Up to 28 days after inclusion
VAC and iVAC
Ventilator associated Condition and infectious iVAC
Measured: Up to 28 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start31 Oct 2018
- Primary completion8 May 2020
- Study completion8 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventilator-associated PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bactiguard AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benoit Misset, MD,Prof., Principal investigator, CHU, Liege; Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242706
- Sponsor's protocol ID
- PL-13674
- Acronym
- VITAL
- Status last verified
- Jan 2021
- First submitted
- 13 Jan 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Damas P, Legrain C, Lambermont B, Dardenne N, Guntz J, Kisoka G, Demaret P, Rousseau AF, Jadot L, Piret S, Noirot D, Bertrand A, Donneau AF, Misset B. Prevention of ventilator-associated pneumonia by noble metal coating of endotracheal tubes: a multi-center, randomized, double-blind study. Ann Intensive Care. 2022 Jan 4;12(1):1. doi: 10.1186/s13613-021-00961-y.
PubMed 34981245
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITAL - VAP Prevention in ICU by BACTIGUARD coAting of endotracheaL Tube
- ClinicalTrials.gov ID
- NCT04242706
- Acronym / sponsor ID
- VITAL / PL-13674
- Conditions
- Ventilator-associated Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Bactiguard ABIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 8 May 2020 (actual)
- Study completion
- 8 May 2020 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled study. Two interventions: 1. Endotracheal tube with evacuation lumen without Bactiguard coating. 2. Endotracheal tube with evacuation lumen with Bactiguard coating.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: ETTEvacEndotracheal tube with evacuation lumen without Bactiguard coating. |
| Experimental group | Experimental | Device: BIP ETTEvacEndotracheal tube with evacuation lumen with Bactiguard coating. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- intubation with a study tube and a presumed duration of ventilation for more than 24h,
- age > 18 y,
- signed informed consent
Key exclusion criteria (4 listed)
- tracheostomized patient
- life expectancy less than 48h,
- previous participation in the study
- pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETTEvacEndotracheal tube with evacuation lumen without noble metal coating | Device | Control group |
| BIP ETTEvacEndotracheal tube with evacuation lumen with noble metal coating | Device | Experimental group |
Primary outcome
VAP incidence
Time frame: Up to 28 days after inclusion
Ventilator Associated Pneumonia incidence
8 secondary outcomes
Nosocomial infections
Time frame: Up to 28 days after inclusion
VAT incidence
Time frame: Up to 28 days after inclusion
Antibiotics consumption
Time frame: Up to 28 days after inclusion
Duration of ventilation
Time frame: Up to 28 days after inclusion
Duration of ICU and hospital stay
Time frame: Up to 28 days after inclusion
Mortality
Time frame: Up to 60 days after inclusion
Tracheal bacterial colonization
Time frame: Up to 28 days after inclusion
VAC and iVAC
Time frame: Up to 28 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 34981245Damas P, Legrain C, Lambermont B, Dardenne N, Guntz J, Kisoka G, Demaret P, Rousseau AF, Jadot L, Piret S, Noirot D, Bertrand A, Donneau AF, Misset B. Prevention of ventilator-associated pneumonia by noble metal coating of endotracheal tubes: a multi-center, randomized, double-blind study. Ann Intensive Care. 2022 Jan 4;12(1):1. doi: 10.1186/s13613-021-00961-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit Misset, MD,Prof. principal investigator
CHU, Liege; Belgium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ETTEvac and BIP ETTEvac in people with Ventilator-associated Pneumonia, run by Bactiguard AB at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAP incidence (time frame: Up to 28 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.