Steriwave ICU Pilot Study

NCT06867458 | Completed

• 1 other identifier: 2024142
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hospital Acquired Infections; Hospital Acquired Pneumonia; Nasal Decolonization of Staphylococcus Aureus; Ventilator Acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Change in nasal bacterial load

  Entire study duration- up to 4 months

• Preliminary Microbiology Data

  Entire study duration- up to 4 months

• HAP incidence

  Entire study duration- up to 4 months

• VAP incidence

  Entire study duration- up to 4 months

• ICU-acquired BSI incidence

  Entire study duration- up to 4 months

Study Arms (2)

Control Arm

NO INTERVENTION

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.

Intervention Arm

EXPERIMENTAL

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

Interventions

Antimicrobial photodynamic therapy (aPDT) nasal decolonization device 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.

Intervention Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fraser Health: lead
• Ondine Biomedical Inc.: collaborator
• Royal Columbian Hospital Foundation: collaborator

Study Sites (1)

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

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

• Steven Reynolds

  Fraser Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Critical Care Physician

Model Details: The pilot study will take place over four months at the Royal Columbian Hospital (RCH) Intensive Care Units. All patients who meet inclusion/exclusion criteria will be enrolled via a waived consent procedure. The first two months will constitute the control period before the aPDT intervention is introduced into the unit. All patients enrolled in the study will receive a nasal swab upon ICU admission, and once every four days during their stay. Following the control period, the intervention period will commence with the introduction of the aPDT device to all eligible patients. Nasal decolonization procedures will be administered every other day. Patients will undergo one follow-up visit at 4 days post ICU discharge.

Study Record Dates

• First Submitted: March 1, 2025
• First Posted: March 10, 2025
• Study Start: March 18, 2025
• Primary Completion: July 18, 2025
• Study Completion: December 31, 2025
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

CA (1)