Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
400 participants
INTERVENTIONAL
2025-03-31
2025-08-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nasal Photodisinfection in All Patients Presenting for Surgery for a Wide Range of Surgical Procedures
NCT05090657
A Cohort Study on Anti-microbial Stewardship in PICU
NCT05862688
Using Antibiotics Wisely - An Antimicrobial Stewardship Program
NCT04388293
Pilot Study of the Utility of Empiric Antibiotic Therapy for Suspected ICU-Acquired Infection
NCT00438269
Reduction of Bacterial Resistance With Inhaled Antibiotics in the Intensive Care Unit
NCT01878643
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Arm
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.
No interventions assigned to this group
Intervention Arm
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
Antimicrobial photodynamic therapy (aPDT) nasal decolonization 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Antimicrobial photodynamic therapy (aPDT) nasal decolonization 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Expected length of ICU stay \>48 hrs
Exclusion Criteria
* 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.
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ondine Biomedical Inc.
INDUSTRY
Royal Columbian Hospital Foundation
OTHER
Fraser Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Steve Reynolds
Critical Care Physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Reynolds
Role: PRINCIPAL_INVESTIGATOR
Fraser Health Authority
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal Columbian Hospital
New Westminster, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024142
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.