400 Participants Needed

Antimicrobial Photodynamic Therapy for Hospital-Acquired Infections

JW
Overseen ByJessica Wittman Research Coordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Fraser Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is antimicrobial photodynamic therapy (aPDT) safe for humans?

The research does not provide specific safety data for humans, but antimicrobial photodynamic therapy (aPDT) is being explored as an alternative to antibiotics, suggesting it is considered a promising and potentially safe option for treating infections.12345

How is antimicrobial photodynamic therapy different from other treatments for hospital-acquired infections?

Antimicrobial photodynamic therapy (aPDT) is unique because it uses light to activate a special compound that produces a form of oxygen toxic to bacteria, making it effective even against antibiotic-resistant strains. Unlike traditional antibiotics, aPDT does not contribute to the development of resistance and can be combined with antibiotics or antifungals for enhanced effectiveness.12467

What data supports the effectiveness of the treatment Antimicrobial photodynamic therapy (aPDT) for hospital-acquired infections?

Research shows that antimicrobial photodynamic therapy (aPDT) can effectively reduce bacterial infections, including those caused by antibiotic-resistant bacteria, by using light and a special dye to kill germs. Studies have found that aPDT can be particularly useful for treating skin and soft tissue infections, and it works well even when combined with antibiotics or antifungal drugs to enhance its effectiveness.12689

Who Is on the Research Team?

SR

Steven Reynolds

Principal Investigator

Fraser Health Authority

Are You a Good Fit for This Trial?

This trial is for patients in the critical care unit at Royal Columbian Hospital who may be at risk of hospital-acquired pneumonia or bloodstream infections. The study aims to include those who could benefit from nasal decolonization to prevent these infections.

Inclusion Criteria

Expected length of ICU stay >48 hrs
I am 19 or older and currently in the ICU.

Exclusion Criteria

I have had an injury to my face or nose that makes it hard to access my nose.
Inability for the patients to tolerate or comply with treatment, as determined by their treating physician
Co-enrolment with other research studies will be considered on an individual basis.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

The first two months will constitute the control period before the aPDT intervention is introduced. No nasal decolonization procedures will take place at this time.

8 weeks
Nasal swab upon ICU admission and every four days

Intervention Period

Nasal decolonization procedures will be administered every other day. Nasal swabs will be collected every four days to assess microbiology.

8 weeks
Nasal swab every four days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a nasal swab collected 4-days post-ICU discharge if still hospitalized.

4 weeks
One additional nasal swab 4-days post-ICU discharge

What Are the Treatments Tested in This Trial?

Interventions

  • Antimicrobial photodynamic therapy (aPDT)
Trial Overview The Steriwave ICU Pilot Study is testing a new antimicrobial photodynamic therapy (aPDT) device for nasal decolonization, aiming to prevent pneumonia and bloodstream infections in ICU patients.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention ArmExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fraser Health

Lead Sponsor

Trials
49
Recruited
708,000+

Royal Columbian Hospital Foundation

Collaborator

Ondine Biomedical Inc.

Industry Sponsor

Trials
8
Recruited
5,700+

Royal Columbian Hospital Foundation

Collaborator

Trials
4
Recruited
1,000+

Published Research Related to This Trial

Antimicrobial photodynamic therapy (aPDT) combined with antimicrobials, particularly using 5-aminolevulinic acid or phenothiazinium dyes, shows promise in treating skin and mucosal infections by reducing treatment times and drug dosages.
The mechanism of action suggests that aPDT damages microbial cell walls, enhancing the effectiveness of antimicrobial drugs, which could help combat drug resistance, although the study's limitations include a small number of heterogeneous studies and a lack of clinical trials.
A combination of photodynamic therapy and antimicrobial compounds to treat skin and mucosal infections: a systematic review.[2020]
Combining antimicrobial photodynamic therapy (aPDT) with antibiotics or antifungals can enhance the effectiveness of treatments against bacteria and fungi, particularly in skin and soft tissue infections, by increasing microbial susceptibility to aPDT.
This combination approach not only helps prevent the regrowth of resistant microorganisms but also reduces the risk of developing antimicrobial resistance, making it a promising strategy in combating highly resistant strains.
Photodynamic Therapy Combined with Antibiotics or Antifungals against Microorganisms That Cause Skin and Soft Tissue Infections: A Planktonic and Biofilm Approach to Overcome Resistances.Pérez-Laguna, V., García-Luque, I., Ballesta, S., et al.[2021]

Citations

A combination of photodynamic therapy and antimicrobial compounds to treat skin and mucosal infections: a systematic review. [2020]
Photodynamic Therapy Combined with Antibiotics or Antifungals against Microorganisms That Cause Skin and Soft Tissue Infections: A Planktonic and Biofilm Approach to Overcome Resistances. [2021]
Evaluation of antimicrobial photodynamic activities of 5-aminolevulinic acid derivatives. [2021]
Evaluation of antimicrobial photodynamic therapy on wounds infected by Staphylococcus aureus in animal models. [2021]
Antimicrobial Photodynamic Therapy: An Effective Alternative Approach to Control Bacterial Infections. [2023]
Antimicrobial photodynamic activity of toluidine blue-carbon nanotube conjugate against Pseudomonas aeruginosa and Staphylococcus aureus - Understanding the mechanism of action. [2020]
Mathematical modelling for antimicrobial photodynamic therapy mediated by 5-aminolaevulinic acid: An in vitro study. [2022]
A comparison of antibacterial and antibiofilm efficacy of phenothiazinium dyes between Gram positive and Gram negative bacterial biofilm. [2019]
Effect of antimicrobial photodynamic therapy on the counts of salivary Streptococcus mutans in children with severe early childhood caries. [2018]
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