Steriwave ICU Pilot Study

This is a single-center, non-blinded, prospective, pilot study enrolling patients admitted to the critical care unit at Royal Columbian Hospital. This study investigates the effects of universal nasal decolonization using antimicrobial photodynamic therapy (aPDT) on the prevention of hospital-acquired pneumonia (HAP), ventilator-acquired pneumonia (VAP), and hospital-acquired bloodstream infection (BSI) in this patient population.

Main Objectives include:

• To determine whether a large, multi-center RCT of this protocol is feasible
• To determine baseline rates of VAP, HAP, and ICU-acquired BSI
• To gather preliminary efficacy data regarding VAP, HAP, and ICU-acquired BSI prevention using universal aPDT nasal decolonization
• To gather preliminary microbiological data on the effect of universal aPDT procedures on nasal carriage of various microoganisms in ICU patients.

Study Overview

• Status: Completed
• Conditions: Hospital Acquired Pneumonia; Ventilator Acquired Pneumonia; Hospital Acquired Infections; Nasal Decolonization of Staphylococcus Aureus
• Intervention / Treatment: Device: Antimicrobial photodynamic therapy (aPDT) nasal decolonization device

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W7
      • Royal Columbian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All ICU patients 19 years and above
• Expected length of ICU stay >48 hrs

Exclusion Criteria:

• Pregnant/breastfeeding individuals
• Allergy to methylene blue and/or chlorhexidine gluconate, or unknown allergy status
• Nasal or facial trauma that limits access to the nose
• Inability for the patients to tolerate or comply with treatment, as determined by their treating physician
• Patient, TSDM or MRP declines participation
• Co-enrolment with other research studies will be considered in an individual basis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Arm; The first two months will constitute the control period before the aPDT intervention is introduced into the unit. No nasal decolonization procedures (current standard of care) will take place at this time. All patients enrolled in the study will receive a nasal swab upon ICU admission, and once every four days during their stay.
Experimental: Intervention Arm; Nasal decolonization procedures will be administered every other day. Just as during the intervention period, a nasal swab will be administered every four days to assess the microbiology of the nose prior to the scheduled nasal decontamination treatment	Device: Antimicrobial photodynamic therapy (aPDT) nasal decolonization device; aPDT is a technique that employs a specific wavelength of light to activate a photosensitizer substance. Once activated, this photosensitizer reacts with surrounding molecules to produce radicals and reactive oxygen species. When activated in the presence of microorganisms, these molecules serve to disrupt membrane structure and protein cross-linking, leading to their death.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protocol Adherance	During each day of the study, members of the research team will track adherence to the nasal swab and nasal decolonization procedures (during the intervention phase) for all patients enrolled in the study. A standardized checklist will be developed and used to track protocol adherence.	Entire study duration- 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nasal bacterial load	Change in nasal bacterial load will be measured by a decrease in semi-quantitative (1+ to 4+) growth on blood agar plates. Nasal swab samples will be collected on every 4th day of the patients ICU stay, with one additional swab collected 4-days post- ICU discharge, should the patient remain hospitalized at the same institution.	Entire study duration- up to 4 months
Preliminary Microbiology Data	Change in CPO, MRSA, MSSA, and MDR gram-negative (Pseudomonas and SPACE organisms) carriage rates. Nasal swab samples will be collected on every 4th day of the patients ICU stay, with one additional swab collected 4-days post- ICU discharge, should the patient remain hospitalized at the same institution.	Entire study duration- up to 4 months
HAP incidence	HAP will be diagnosed according to the Fraser Health Antimicrobial Stewardship Program (ASP) Hospital Acquired Pneumonia definition. This document defines a HAP event as "pneumonia that occurs 48 hours or more after admission and was not present at the time of admission." Whether or not a patient is diagnosed with pneumonia will be adjudicated according to the January 2024 National Health and Safety Network (NHSN) diagnosis algorithm. Additionally, if the patients treating physician diagnoses the patient with HAP, this will be considered sufficient to include as a study outcome. Data needed to adjudicate this outcome will be collected from patient charts by members of the research team. This data will be compiled for analysis by the same committee as noted above.	Entire study duration- up to 4 months
VAP incidence	As above, VAP will also be diagnosed according to Fraser Health ASP Ventilator- Associated Pneumonia definition, as a "pneumonia that occurs 48 hours after endotracheal intubation." The causative organism must be different than an organism present form any index infection prior to the ICU stay. The presence of pneumonia will be similarly adjudicated according to the NHSN diagnosis algorithm. Any mention of VAP in the physicians progress notes will also be deemed sufficient for study outcomes.	Entire study duration- up to 4 months
ICU Readmission	Number of patients re-admitted to the ICU during the 4-day follow-up	Entire study duration- 4 months
LOS- Hospital	Hospital length of stay (days)	Entire study duration- 4 months
LOS- ICU	ICU length of stay (days)	Entire study duration- 4 months
ICU-acquired BSI incidence	ICU-acquired BSI will be diagnosed in accordance with the CDC National Healthcare Safety Network BSI definition from January 2024, described as "a laboratory confirmed bloodstream infection that is not secondary to an infection at another site". In order for the infection to be considered ICU-acquired, the patient must have tested for a new pathogen (that is not a common commensal) 48 hours after their ICU admission date. The investigators will consider a BSI from any cause as contributing to this outcome.	Entire study duration- up to 4 months
Ability to adjudicate HAP occurrence effectively	The investigators will consider adjudication effective if the process can be completed using data collected in the study CRFs within 30 days of protocol completion.	Entire study duration- 4 months
Ability to adjudicate VAP occurrence effectively	The investigators will consider adjudication effective if the process can be completed using data collected in the study CRFs within 30 days of protocol completion.	Entire study duration- 4 months
In-hospital mortality up to 60 days post intervention	At 60 days post-ICU admission, patient death data will be recorded as it is available from the same visit on the EMR. Data will not be collected on any information that occurred outside of the immediate study visit. Participants who have been discharged from the hospital will not be contacted by the research team.	One time measurement, 60 days post- ICU admission

Collaborators and Investigators

• Sponsor: Fraser Health
• Collaborators: Ondine Biomedical Inc.; Royal Columbian Hospital Foundation
• Investigators: Principal Investigator: Steven Reynolds, Fraser Health Authority

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2025
• Primary Completion (Actual): July 18, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: March 1, 2025
• First Submitted That Met QC Criteria: March 6, 2025
• First Posted (Actual): March 10, 2025

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 2024142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De-identified data set may be available upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No