Steriwave ICU Pilot Study

Fraser Health

Status: Not yet enrolling

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

Treatments: Device: Antimicrobial photodynamic therapy (aPDT) nasal decolonization device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06867458

2024142

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Control Arm

No Intervention group

Description:

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 group

Description:

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

Treatment:

Device: Antimicrobial photodynamic therapy (aPDT) nasal decolonization device