Clinical trial NCT06867458: Steriwave ICU Pilot Study
Official title: Steriwave ICU Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ventilator Acquired Pneumonia
Hospital Acquired Pneumonia
Hospital Acquired Infections
Nasal Decolonization of Staphylococcus Aureus
Lead sponsor: Fraser Health
Sponsor class: OTHER
Collaborators: name: Ondine Biomedical Inc.
name: Royal Columbian Hospital Foundation
First posted: 2025-03-10
Enrollment: 400
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Protocol Adherance
timeFrame: Entire study duration- 4 months
Secondary outcomes:
measure: Change in nasal bacterial load
timeFrame: Entire study duration- up to 4 months
measure: Preliminary Microbiology Data
timeFrame: Entire study duration- up to 4 months
measure: HAP incidence
timeFrame: Entire study duration- up to 4 months
measure: VAP incidence
timeFrame: Entire study duration- up to 4 months
measure: ICU-acquired BSI incidence
timeFrame: Entire study duration- up to 4 months
measure: Ability to adjudicate HAP occurrence effectively
timeFrame: Entire study duration- 4 months
measure: Ability to adjudicate VAP occurrence effectively
timeFrame: Entire study duration- 4 months
measure: ICU Readmission
timeFrame: Entire study duration- 4 months
measure: LOS- Hospital
timeFrame: Entire study duration- 4 months
measure: LOS- ICU
timeFrame: Entire study duration- 4 months
measure: In-hospital mortality up to 60 days post intervention
timeFrame: One time measurement, 60 days post- ICU admission
Other outcomes:
Locations:
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
Study officials:
affiliation: Fraser Health Authority
name: Steven Reynolds
role: PRINCIPAL_INVESTIGATOR
References: