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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
400
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.
Royal Columbian Hospital
New Westminster, British Columbia, Canada
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.
Time frame: Entire study duration- 4 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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. We will consider a BSI from any cause as contributing to this outcome.
Time frame: Entire study duration- up to 4 months
Ability to adjudicate HAP occurrence effectively
We will consider adjudication effective if we are able to complete the process using data collected in the study CRFs within 30 days of protocol completion.
Time frame: Entire study duration- 4 months
Ability to adjudicate VAP occurrence effectively
We will consider adjudication effective if we are able to complete the process using data collected in the study CRFs within 30 days of protocol completion.
Time frame: Entire study duration- 4 months
ICU Readmission
Number of patients re-admitted to the ICU during the 4-day follow-up
Time frame: Entire study duration- 4 months
LOS- Hospital
Hospital length of stay (days)
Time frame: Entire study duration- 4 months
LOS- ICU
ICU length of stay (days)
Time frame: Entire study duration- 4 months
In-hospital mortality up to 60 days post intervention
At 60 days post-ICU admission, we will record information about patient death as it is available from the same visit on the EMR. We will not gather data on any information that occurred outside of the immediate study visit. We will not contact participants who have been discharged from the hospital.
Time frame: One time measurement, 60 days post- ICU admission
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