Ventilator Acquired PneumoniaNCT06867458

Steriwave ICU Pilot Study

A study testing Antimicrobial photodynamic therapy (aPDT) nasal decolonization device in people with Ventilator Acquired Pneumonia and Hospital Acquired Pneumonia, run by Fraser Health at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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)… Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Ventilator Acquired Pneumonia, Hospital Acquired Pneumonia, Hospital Acquired Infections
What is being tested?: Antimicrobial photodynamic therapy (aPDT) nasal decolonization device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 227 participants
Where: 1 siteCanada
Study dates: 18 Mar 2025to 31 Dec 2025
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 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

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: Ventilator Acquired Pneumonia, Hospital Acquired Pneumonia, Hospital Acquired Infections, Nasal Decolonization of Staphylococcus Aureus
Being tested: Antimicrobial photodynamic therapy (aPDT) nasal decolonization device
Medical subject headings: Pneumonia, Ventilator-Associated, Healthcare-Associated Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Antimicrobial photodynamic therapy (aPDT) nasal decolonization deviceDevice
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.

Study groups in NCT06867458
Study group	Role	What they receive
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 Receives: Device: Antimicrobial photodynamic therapy (aPDT) nasal decolonization device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Entire study duration- 4 months

Secondary outcomes (11)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Entire study duration- up to 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.
Measured: 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.
Measured: 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.
Measured: Entire study duration- 4 months
ICU Readmission
Number of patients re-admitted to the ICU during the 4-day follow-up
Measured: Entire study duration- 4 months
LOS- Hospital
Hospital length of stay (days)
Measured: Entire study duration- 4 months
LOS- ICU
ICU length of stay (days)
Measured: 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.
Measured: One time measurement, 60 days post- ICU admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 202531 Dec 2025

First posted10 Mar 2025
Study start18 Mar 2025
Primary completion18 Jul 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Ventilator Acquired 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: Sequential
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 227 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06867458
Sponsor's protocol ID: 2024142
Status last verified: Mar 2026
First submitted: 1 Mar 2025
Last updated: 5 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: De-identified data set may be available upon reasonable request.

Publications

Rohrs E, Ornowska M, Wittmann J, Hernandez S, Reynolds C, Dakin I, Zhang L, Whellams D, Masud S, Reynolds S. Suppression of microbial burden to reduce pneumonia in critical illness: the SMURF feasibility pilot study. Crit Care. 2026 Apr 7;30(1):268. doi: 10.1186/s13054-026-06008-7.
PubMed 41947247

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
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Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 2
A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia
Not yet recruiting
Resistance-Optimised Antimicrobial Dosing in Critically Ill Patients, a Randomised Controlled Trial
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All Ventilator Acquired Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Steriwave ICU Pilot Study
ClinicalTrials.gov ID: NCT06867458
Acronym / sponsor ID: 2024142
Conditions: Ventilator Acquired Pneumonia, Hospital Acquired Pneumonia, Hospital Acquired Infections, Nasal Decolonization of Staphylococcus Aureus
Study type: Interventional
Recruitment status: Completed
Enrolment: 227 participants (actual)
Lead sponsor: Fraser HealthUniversity, hospital or other
Collaborators: Ondine Biomedical Inc., Royal Columbian Hospital Foundation
Study start: 18 Mar 2025 (actual)
Primary completion: 18 Jul 2025 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 10 Mar 2025 (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.

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 design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
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	Device: Antimicrobial photodynamic therapy (aPDT) nasal decolonization deviceNasal 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

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

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
Antimicrobial photodynamic therapy (aPDT) nasal decolonization deviceaPDT 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.	Device	Intervention Arm

Primary outcome

Protocol Adherance
Time frame: Entire study duration- 4 months
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.

11 secondary outcomes

Change in nasal bacterial load
Time frame: Entire study duration- up to 4 months
Preliminary Microbiology Data
Time frame: Entire study duration- up to 4 months
HAP incidence
Time frame: Entire study duration- up to 4 months
VAP incidence
Time frame: Entire study duration- up to 4 months
ICU-acquired BSI incidence
Time frame: Entire study duration- up to 4 months
Ability to adjudicate HAP occurrence effectively
Time frame: Entire study duration- 4 months
Ability to adjudicate VAP occurrence effectively
Time frame: Entire study duration- 4 months
ICU Readmission
Time frame: Entire study duration- 4 months
LOS- Hospital
Time frame: Entire study duration- 4 months
LOS- ICU
Time frame: Entire study duration- 4 months
In-hospital mortality up to 60 days post intervention
Time frame: One time measurement, 60 days post- ICU admission

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
Derived from this study: PubMed 41947247Rohrs E, Ornowska M, Wittmann J, Hernandez S, Reynolds C, Dakin I, Zhang L, Whellams D, Masud S, Reynolds S. Suppression of microbial burden to reduce pneumonia in critical illness: the SMURF feasibility pilot study. Crit Care. 2026 Apr 7;30(1):268. doi: 10.1186/s13054-026-06008-7.
Individual participant dataSharing planned: Undecided. De-identified data set may be available upon reasonable request.

Related trials for Ventilator Acquired Pneumonia

RecruitingPhase 4
EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
Blood Stream Infections, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
Hospital Acquired Bacterial Pneumonia (HABP), Ventilator Associated Bacterial Pneumonia (VABP)
Active, not recruiting
HAP/VAP Diagnosis in Critically Ill Septic Patients Using a Multiplex PCR Array
HAP - Hospital Acquired Pneumonia, VAP - Ventilator Associated Pneumonia
RecruitingPhase 2
A Clinical Trial to Assess the Safety and PK of OMN6 in HABP or VABP Caused by Acinetobacter Baumannii Complex
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Not yet recruiting
Resistance-Optimised Antimicrobial Dosing in Critically Ill Patients, a Randomised Controlled Trial
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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.

Steven Reynolds principal investigator

Fraser Health Authority

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 6 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: finished, as of the sponsor's last update on 5 Mar 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Protocol Adherance (time frame: Entire study duration- 4 months). 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 NCT06867458, which also lists 1 linked publication.

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 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.