Antimicrobial Photodynamic Therapy for Hospital-Acquired Infections

Overseen By Jessica Wittman Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fraser Health

Disqualifiers: Pregnant, Allergy, Nasal trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to prevent infections in ICU patients using antimicrobial photodynamic therapy (aPDT). This involves applying a special light and substance to the nose to kill germs. The study will compare patients receiving this treatment with those who do not, to determine if it reduces infections such as pneumonia and bloodstream infections. Patients who have been in the ICU for more than two days and do not have nasal injuries or certain allergies might be suitable candidates. As an unphased trial, this study provides an opportunity for patients to contribute to innovative research that could enhance infection prevention in critical care settings.

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.

What prior data suggests that this protocol is safe for preventing hospital-acquired infections?

Research has shown that antimicrobial photodynamic therapy (aPDT) could effectively kill various bacteria, including those responsible for hospital infections. Studies have found that aPDT can reduce harmful bacteria on hospital surfaces, potentially preventing infections like pneumonia or bloodstream infections.

Regarding safety, aPDT is generally well-tolerated. Previous studies have not identified any major safety issues, supported by its use in treating other conditions, such as dental biofilms. While further research is needed to confirm these findings, current evidence suggests that aPDT is a safe option for reducing bacterial infections. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for hospital-acquired infections, which typically involves antibiotics, antimicrobial photodynamic therapy (aPDT) uses light-sensitive compounds and a specific wavelength of light to destroy harmful bacteria. This method is unique because it targets bacteria directly, minimizing the risk of antibiotic resistance, a major concern with current treatments. Moreover, aPDT can be precisely applied to infected areas, potentially reducing side effects associated with systemic antibiotic use. Researchers are excited about this approach because it offers a novel, potentially more effective way to manage infections without contributing to the growing issue of antibiotic resistance.

What evidence suggests that antimicrobial photodynamic therapy is effective for preventing hospital-acquired infections?

Research has shown that antimicrobial photodynamic therapy (aPDT) can significantly reduce bacteria, including resistant strains like MRSA. In studies, aPDT consistently reduced these bacteria by 99.9%. It uses light to activate a substance that kills harmful germs. In this trial, participants in the intervention arm will receive aPDT as part of nasal decolonization procedures. When combined with antibiotics, aPDT can enhance treatment effectiveness and help prevent antibiotic resistance. It has proven effective and generally well-tolerated in various situations. However, infections can sometimes return, so ongoing treatment might be necessary. ^{1 2 5 6 7}

Who Is on the Research Team?

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.

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?

Group I: Intervention Arm Experimental Treatment 1 Intervention

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

Group II: Control Arm Active Control 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1.

academic.oup.com

academic.oup.com/ofid/article/10/Supplement_2/ofad500.2408/7447191

2797. Antimicrobial Photodynamic Therapy (aPDT) Is Highly ...

Relative to untreated controls, aPDT resulted in a minimum reduction of 3log10 (99.9%) against all MRSA strains tested, with the commercial ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12519489/

Synergistic Paradigms in Infection Control: A Review on ...

The current state of knowledge suggests that, when used alongside antibiotics, aPDT can improve treatment efficacy, reduce antimicrobial ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S019567012400286X

Photodynamic coatings kill bacteria on near-patient ...

Both photodynamic AMCs offer a substantial, permanent risk reduction of microbial counts on near patient surfaces in ICUs with low light intensities.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8705969/

Antimicrobial Photodynamic Therapy: Latest Developments ...

Results demonstrated that aPDT is effective and well-tolerated, but infections can recur frequently [71,72]. Among cutaneous infections, non-healing chronic ...

5.

frontiersin.org

frontiersin.org/journals/microbiology/articles/10.3389/fmicb.2018.01299/full

Antimicrobial Photodynamic Therapy to Control Clinically ...

Bacteriophage therapy is effective in combating wound biofilm infections and implant- and catheter-related infections (Burrowes et al., 2011; Alemayehu et al., ...

6.

pubs.acs.org

pubs.acs.org/doi/10.1021/acsinfecdis.5c00369

Synergistic Paradigms in Infection Control: A Review on ...

The data suggest that traditional aPDT has not yet dominated debates on combating antimicrobial resistance. In this sense, new alternatives, ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8618630/

Impact of Healthcare-Associated Infections Connected to ...

This review elucidates the impact of HAIs, focusing on device-associated infections such as central line-associated bloodstream infection including catheter ...