Ceragenin Coated Endotracheal Tubes for the Prevention of Ventilator Associated Pneumonia

NCT05761613 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 6036323
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

  Admission to within 48 hours of cessation of invasive mechanical ventilation or 28 days

Secondary Outcomes (9)

• Antibiotic Utilization

  28 days after intubation

• Health care utilization

  90 days

• Health care utilization

  28 days

• Hospital Mortality

  90 days

• Airway outcomes

  Within 48 hours of extubation

Study Arms (2)

Endotracheal Tube with Subglottic Secretion Drainage

ACTIVE COMPARATOR

All patients in this arm will be intubated with an ETT with subglottic secretion drainage

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

Device: CeraShield Endotracheal Tube

Interventions

CeraShield Endotracheal Tube DEVICE

An endotracheal tube coated with with an antimicrobial hydrophilic coating containing ceragenins (CSAs)

CeraShield Endotracheal Tube

Endotracheal tube with subglottic secretion drainage DEVICE

An endotracheal tube with subglottic secretion drainage

Endotracheal Tube with Subglottic Secretion Drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult critically ill patients with respiratory failure requiring intubation

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. John Muscedere: lead

Study Sites (1)

Kingston Health Sciences Center

Kingston, Ontario, K7L2V7, Canada

Location

Related Publications (7)

• 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.

  PMID: 16215368 BACKGROUND

• Muscedere 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.

  PMID: 20597661 BACKGROUND

• Muscedere 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.

  PMID: 21478738 BACKGROUND

• Diaconu 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.

  PMID: 30581995 BACKGROUND

• Epand 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.

  PMID: 18836587 BACKGROUND

• Grimshaw 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.

  PMID: 10735262 BACKGROUND

• Symonds 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.

  PMID: 38309761 DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John MUSCEDERE, MD

  Queens University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All pneumonia outcomes will be adjudicated by a panel blinded to allocation
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 9, 2023
• Study Start: February 21, 2023
• Primary Completion: March 28, 2024
• Study Completion: December 1, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)