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| Name | Class |
|---|---|
| Ondine Biomedical Inc. | INDUSTRY |
| Royal Columbian Hospital Foundation | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Reynolds | Fraser Health Authority | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Columbian Hospital | New Westminster | British Columbia | V3L 3W7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41947247 | Derived | 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. |
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De-identified data set may be available upon reasonable request.
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| ID | Term |
|---|---|
| D053717 | Pneumonia, Ventilator-Associated |
| D000077299 | Healthcare-Associated Pneumonia |
| ID | Term |
|---|---|
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
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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.
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| 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-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 |
| 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 |
| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |