Ventilator Associated PneumoniaCEASEVAPNCT05761613
Ceragenin Coated Endotracheal Tubes for the Prevention of Ventilator Associated Pneumonia
A study testing CeraShield Endotracheal Tube and Endotracheal tube with subglottic secretion drainage in people with Ventilator Associated Pneumonia, run by Dr. John Muscedere at 1 site in Canada.
Trial summary
Critically ill patients are at high risk of acquiring pneumonia during the time that they are mechanically ventilated. This is known as ventilator-associated pneumonia (VAP). VAP results in increased duration of mechanical ventilation, increased ICU and hospital stay, increased risk of death and increased health care… 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?
- CeraShield Endotracheal Tube and Endotracheal tube with subglottic secretion drainage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteCanada
- Study dates
- 21 Feb 2023to 1 Dec 2024
- Phase
- Interventional
- 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
- Adult critically ill patients with respiratory failure requiring intubation
Who cannot join
- Admission to hospital or ICU with a non-study ETT already in place
- Presence of a tracheostomy on ICU admission
- Unable to be intubated with non-study ETT
- Declined participation in research or data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ceragenin Coated Endotracheal Tubes for the Eradication of Ventilator Associated Pneumonia - A Prospective, Longitudinal, Cross-over, Interrupted Time, Implementation Study (CEASE VAP Study)
Critically ill patients are at high risk of acquiring pneumonia during the time that they are mechanically ventilated. This is known as ventilator-associated pneumonia (VAP). VAP results in increased duration of mechanical ventilation, increased ICU and hospital stay, increased risk of death and increased health care costs. VAP occurs in 20% of patients and it is estimated that each case of VAP costs the health care system $10 to 15,000 Canadian. Because of its impact on patient outcomes and the health care system, VAP is regarded as an important patient safety issue and there is an urgent need for better prevention strategies.
Invasive mechanical ventilation requires the passage of an endotracheal tube (ETT) through the pharynx which is frequently colonized with bacterial pathogens and a bio-film rapidly forms on the ETT. VAP results either from aspiration of contaminated oropharyngeal secretions or from aspiration of bacteria from the bio-film. In this project, the efficacy of a novel ETT coated with an antibiotic compound that has been shown to reduce the formation of bio-film and pathogen colonization will be tested. Preliminary evidence as to whether utilization of this novel ETT reduces the occurrence of VAP and improves patient outcomes will be obtained through the conduct of a pragmatic, prospective, longitudinal, interrupted time, cross-over implementation study.
Read the detailed description
The innovation that is being studied is a novel antibiotic coated endotracheal tube (ETT) for the prevention of ventilator associated pneumonia (VAP) in critically ill, mechanically ventilated patients. The novel ETT is the CeraShield ETT consisting of a standard ETT with an antimicrobial hydrophilic coating containing ceragenins (CSAs) on the inner and outer lumen of the device, as well as the inflatable cuff. The CSA coating on the CeraShield protects it from microbial colonization and bio-film growth. The CSA ETT is otherwise equivalent to standard ETT tubes currently in use and is licensed in Canada for clinical use as a Class 2 device.
- It is hypothesized that CSA coated ETTs will reduce the incidence of Ventilator Associated Pneumonia and improve clinical outcomes including antibiotic utilization when compared to ETTs currently in use.
- It is hypothesized that a definitive cluster randomized multi-center study is feasible and supported by the data from this study.
To test the hypotheses, an Interrupted Time Series Cross-Over Implementation Study will be used to provide preliminary evidence of the efficacy of the CeraShield ETT compared to the ETT currently used at the study center in critically ill mechanically ventilated patients. This study will inform and be modified to conduct a future large multi-center cluster randomized study.
- Conditions
- Ventilator Associated Pneumonia
- Being tested
- CeraShield Endotracheal Tube, Endotracheal tube with subglottic secretion drainage
- 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.
CeraShield Endotracheal TubeDevice
An endotracheal tube coated with with an antimicrobial hydrophilic coating containing ceragenins (CSAs)
Endotracheal tube with subglottic secretion drainageDevice
An endotracheal tube with subglottic secretion drainage
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal Tube with Subglottic Secretion Drainage | Active comparator | All patients in this arm will be intubated with an ETT with subglottic secretion drainage Receives: Device: Endotracheal tube with subglottic secretion drainage |
| CeraShield Endotracheal Tube | Active comparator | All patients in this arm will be intubated with a ceragenin coated ETT Receives: Device: CeraShield Endotracheal Tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Ventilator Associated Pneumonia
The primary outcome will be the occurrence of VAP defined as new, progressive, or persistent radiographic infiltrate on chest radiograph plus any 2 of the following: (1) fever (core temperature >38°C) or hypothermia (temperature <36°C); (2) white blood cell count less than 3.0 × 106/L or exceeding 10 × 106/L, and (3) purulent sputum
Measured: Admission to within 48 hours of cessation of invasive mechanical ventilation or 28 days
Secondary outcomes (9)
Antibiotic Utilization
Antibiotic free days defined as alive and not recieving antibiotics in the 28 day period after intubation
Measured: 28 days after intubation
Health care utilization
Duration of mechanical ventilation, duration of ICU stay, duration of hospital stay
Measured: 90 days
Health care utilization
Ventilator Free Days defined as alive and off ventilation in the 28 day period after intubation
Measured: 28 days
Hospital Mortality
Mortality while hospitalized
Measured: 90 days
Airway outcomes
Incidence of post-extubation stridor, lack of endotracheal tube cuff leak
Measured: Within 48 hours of extubation
Re-intubation
Rate of re-intubation after extubation from invasive mechanical ventilation
Measured: Within 48 hours of extubation
Acceptability of the Intervention
Measured by the Acceptability of Intervention Measure Tool (AIM). AIM is a 5 point scale that measures the perception of implementation stakeholders that a new treatment (in this study new type of ETT) is agreeable or satisfactory. AIM is an ordinal scale that ranges from completely agree to completely disagree.
Measured: During the conduct of the trial up to 1 year from study initiation
Feasibility of multi-center cluster randomized trial - 1
Determination of required sample size for a multi-center study based on the event rates (Occurrence of VAP as in outcome 1 and antibiotic utilization as in outcome 2) in this single center trial. Sample size will be calculated for the multicenter study and feasibility will be informed by the magnitude of the sample size and the potential resources required to conduct such as study including the number of centers.
Measured: During the trial up to 1 year from study start
Feasibility of multi-center cluster randomized trial - 2
Acceptable availability of routinely collected data for analysis of study conduct defined as less than 10% missing data
Measured: During the trial up to 1 year from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start21 Feb 2023
- Primary completion28 Mar 2024
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. John Muscedere
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. John Muscedere, Queen's University
- Investigators
- John MUSCEDERE, MD, Principal investigator, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761613
- Sponsor's protocol ID
- 6036323
- Acronym
- CEASEVAP
- Status last verified
- Apr 2024
- First submitted
- 23 Feb 2023
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review. Crit Care Med. 2005 Oct;33(10):2184-93. doi: 10.1097/01.ccm.0000181731.53912.d9.
PubMed 16215368Muscedere JG, Day A, Heyland DK. Mortality, attributable mortality, and clinical events as end points for clinical trials of ventilator-associated pneumonia and hospital-acquired pneumonia. Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S120-5. doi: 10.1086/653060.
PubMed 20597661Muscedere J, Rewa O, McKechnie K, Jiang X, Laporta D, Heyland DK. Subglottic secretion drainage for the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis. Crit Care Med. 2011 Aug;39(8):1985-91. doi: 10.1097/CCM.0b013e318218a4d9.
PubMed 21478738Diaconu O, Siriopol I, Polosanu LI, Grigoras I. Endotracheal Tube Biofilm and its Impact on the Pathogenesis of Ventilator-Associated Pneumonia. J Crit Care Med (Targu Mures). 2018 Apr 1;4(2):50-55. doi: 10.2478/jccm-2018-0011. eCollection 2018 Apr.
PubMed 30581995Epand RM, Epand RF, Savage PB. Ceragenins (cationic steroid compounds), a novel class of antimicrobial agents. Drug News Perspect. 2008 Jul-Aug;21(6):307-11. doi: 10.1358/dnp.2008.21.6.1246829.
PubMed 18836587Grimshaw J, Campbell M, Eccles M, Steen N. Experimental and quasi-experimental designs for evaluating guideline implementation strategies. Fam Pract. 2000 Feb;17 Suppl 1:S11-6. doi: 10.1093/fampra/17.suppl_1.s11.
PubMed 10735262Symonds NE, Meng EXM, Boyd JG, Boyd T, Day A, Hobbs H, Maslove DM, Norman PA, Semrau JS, Sibley S, Muscedere J. Ceragenin-coated endotracheal tubes for the reduction of ventilator-associated pneumonia: a prospective, longitudinal, cross-over, interrupted time, implementation study protocol (CEASE VAP study). BMJ Open. 2024 Feb 2;14(2):e076720. doi: 10.1136/bmjopen-2023-076720.
PubMed 38309761
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceragenin Coated Endotracheal Tubes for the Eradication of Ventilator Associated Pneumonia - A Prospective, Longitudinal, Cross-over, Interrupted Time, Implementation Study (CEASE VAP Study)
- ClinicalTrials.gov ID
- NCT05761613
- Acronym / sponsor ID
- CEASEVAP / 6036323
- Conditions
- Ventilator Associated Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Dr. John MuscedereUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Mar 2023 (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.
Critically ill patients are at high risk of acquiring pneumonia during the time that they are mechanically ventilated. This is known as ventilator-associated pneumonia (VAP). VAP results in increased duration of mechanical ventilation, increased ICU and hospital stay, increased risk of death and increased health care costs. VAP occurs in 20% of patients and it is estimated that each case of VAP costs the health care system $10 to 15,000 Canadian. Because of its impact on patient outcomes and the health care system, VAP is regarded as an important patient safety issue and there is an urgent need for better prevention strategies.
Invasive mechanical ventilation requires the passage of an endotracheal tube (ETT) through the pharynx which is frequently colonized with bacterial pathogens and a bio-film rapidly forms on the ETT. VAP results either from aspiration of contaminated oropharyngeal secretions or from aspiration of bacteria from the bio-film. In this project, the efficacy of a novel ETT coated with an antibiotic compound that has been shown to reduce the formation of bio-film and pathogen colonization will be tested. Preliminary evidence as to whether utilization of this novel ETT reduces the occurrence of VAP and improves patient outcomes will be obtained through the conduct of a pragmatic, prospective, longitudinal, interrupted time, cross-over implementation study.
Detailed description
The innovation that is being studied is a novel antibiotic coated endotracheal tube (ETT) for the prevention of ventilator associated pneumonia (VAP) in critically ill, mechanically ventilated patients. The novel ETT is the CeraShield ETT consisting of a standard ETT with an antimicrobial hydrophilic coating containing ceragenins (CSAs) on the inner and outer lumen of the device, as well as the inflatable cuff. The CSA coating on the CeraShield protects it from microbial colonization and bio-film growth. The CSA ETT is otherwise equivalent to standard ETT tubes currently in use and is licensed in Canada for clinical use as a Class 2 device.
- It is hypothesized that CSA coated ETTs will reduce the incidence of Ventilator Associated Pneumonia and improve clinical outcomes including antibiotic utilization when compared to ETTs currently in use.
- It is hypothesized that a definitive cluster randomized multi-center study is feasible and supported by the data from this study.
To test the hypotheses, an Interrupted Time Series Cross-Over Implementation Study will be used to provide preliminary evidence of the efficacy of the CeraShield ETT compared to the ETT currently used at the study center in critically ill mechanically ventilated patients. This study will inform and be modified to conduct a future large multi-center cluster randomized study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal Tube with Subglottic Secretion Drainage | Active comparator | Device: Endotracheal tube with subglottic secretion drainageAll patients in this arm will be intubated with an ETT with subglottic secretion drainage |
| CeraShield Endotracheal Tube | Active comparator | Device: CeraShield Endotracheal TubeAll patients in this arm will be intubated with a ceragenin coated ETT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult critically ill patients with respiratory failure requiring intubation
Key exclusion criteria (4 listed)
- Admission to hospital or ICU with a non-study ETT already in place
- Presence of a tracheostomy on ICU admission
- Unable to be intubated with non-study ETT
- Declined participation in research or data collection
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 |
|---|---|---|
| CeraShield Endotracheal TubeAn endotracheal tube coated with with an antimicrobial hydrophilic coating containing ceragenins (CSAs) | Device | CeraShield Endotracheal Tube |
| Endotracheal tube with subglottic secretion drainageAn endotracheal tube with subglottic secretion drainage | Device | Endotracheal Tube with Subglottic Secretion Drainage |
Primary outcome
Occurrence of Ventilator Associated Pneumonia
Time frame: Admission to within 48 hours of cessation of invasive mechanical ventilation or 28 days
The primary outcome will be the occurrence of VAP defined as new, progressive, or persistent radiographic infiltrate on chest radiograph plus any 2 of the following: (1) fever (core temperature >38°C) or hypothermia (temperature <36°C); (2) white blood cell count less than 3.0 × 106/L or exceeding 10 × 106/L, and (3) purulent sputum
9 secondary outcomes
Antibiotic Utilization
Time frame: 28 days after intubation
Health care utilization
Time frame: 90 days
Health care utilization
Time frame: 28 days
Hospital Mortality
Time frame: 90 days
Airway outcomes
Time frame: Within 48 hours of extubation
Re-intubation
Time frame: Within 48 hours of extubation
Acceptability of the Intervention
Time frame: During the conduct of the trial up to 1 year from study initiation
Feasibility of multi-center cluster randomized trial - 1
Time frame: During the trial up to 1 year from study start
Feasibility of multi-center cluster randomized trial - 2
Time frame: During the trial up to 1 year from study start
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Background: PubMed 16215368Safdar N, Dezfulian C, Collard HR, Saint S. Clinical and economic consequences of ventilator-associated pneumonia: a systematic review. Crit Care Med. 2005 Oct;33(10):2184-93. doi: 10.1097/01.ccm.0000181731.53912.d9.
- Background: PubMed 20597661Muscedere JG, Day A, Heyland DK. Mortality, attributable mortality, and clinical events as end points for clinical trials of ventilator-associated pneumonia and hospital-acquired pneumonia. Clin Infect Dis. 2010 Aug 1;51 Suppl 1:S120-5. doi: 10.1086/653060.
- Background: PubMed 21478738Muscedere J, Rewa O, McKechnie K, Jiang X, Laporta D, Heyland DK. Subglottic secretion drainage for the prevention of ventilator-associated pneumonia: a systematic review and meta-analysis. Crit Care Med. 2011 Aug;39(8):1985-91. doi: 10.1097/CCM.0b013e318218a4d9.
- Background: PubMed 30581995Diaconu O, Siriopol I, Polosanu LI, Grigoras I. Endotracheal Tube Biofilm and its Impact on the Pathogenesis of Ventilator-Associated Pneumonia. J Crit Care Med (Targu Mures). 2018 Apr 1;4(2):50-55. doi: 10.2478/jccm-2018-0011. eCollection 2018 Apr.
- Background: PubMed 18836587Epand RM, Epand RF, Savage PB. Ceragenins (cationic steroid compounds), a novel class of antimicrobial agents. Drug News Perspect. 2008 Jul-Aug;21(6):307-11. doi: 10.1358/dnp.2008.21.6.1246829.
- Background: PubMed 10735262Grimshaw J, Campbell M, Eccles M, Steen N. Experimental and quasi-experimental designs for evaluating guideline implementation strategies. Fam Pract. 2000 Feb;17 Suppl 1:S11-6. doi: 10.1093/fampra/17.suppl_1.s11.
- Derived from this study: PubMed 38309761Symonds NE, Meng EXM, Boyd JG, Boyd T, Day A, Hobbs H, Maslove DM, Norman PA, Semrau JS, Sibley S, Muscedere J. Ceragenin-coated endotracheal tubes for the reduction of ventilator-associated pneumonia: a prospective, longitudinal, cross-over, interrupted time, implementation study protocol (CEASE VAP study). BMJ Open. 2024 Feb 2;14(2):e076720. doi: 10.1136/bmjopen-2023-076720.
- Individual participant dataSharing planned: No
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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.
John MUSCEDERE, MD principal investigator
Queens University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CeraShield Endotracheal Tube and Endotracheal tube with subglottic secretion drainage in people with Ventilator Associated Pneumonia, run by Dr. John Muscedere at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
Are results available for this study?
Results are not available in the source record.
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?
Occurrence of Ventilator Associated Pneumonia (time frame: Admission to within 48 hours of cessation of invasive mechanical ventilation or 28 days). 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 NCT05761613, which also lists 7 linked publications.
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 5 Apr 2024.