Photodynamic Therapy for Abscess

Not yet recruiting at 1 trial location

Overseen By Ashwani K Sharma, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Rochester

Disqualifiers: Pregnancy, Lactation, Allergy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called methylene blue photodynamic therapy (MB-PDT) to clean out deep tissue abscesses, which are infected pockets filled with pus. The study compares three approaches: two using MB-PDT with different dosing methods plus standard drainage, and one with just standard drainage. The main goal is to determine if MB-PDT can expedite the removal of the drainage catheter. Individuals experiencing symptoms like fever and pain from an abscess requiring drainage might be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that methylene blue photodynamic therapy (MB-PDT) is generally safe for people. In earlier studies, participants experienced no treatment-related side effects and tolerated the therapy well. The optical fibers used in the treatment were easily removed in all cases. Another study found that adding MB-PDT to the usual treatment for abscess drainage was safe and practical, with no safety issues observed in any participants. These findings suggest that MB-PDT is well-tolerated, making it a promising option for those considering joining the clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for abscesses focus on draining the infected area and using antibiotics to clear the infection. However, methylene blue photodynamic therapy (MB-PDT) introduces a novel approach. This treatment uses methylene blue, a special dye, along with laser light to activate a reaction that can kill bacteria directly at the site of the abscess. Researchers are excited because MB-PDT could enhance infection control by targeting bacteria more precisely and potentially reduce reliance on antibiotics, especially important in an era of increasing antibiotic resistance. Additionally, the therapy is tailored; one approach adjusts laser power based on the abscess's characteristics, which might lead to more effective personalized treatment.

What evidence suggests that this trial's treatments could be effective for abscess?

Research has shown that methylene blue photodynamic therapy (MB-PDT) could effectively treat abscesses. In this trial, participants will be assigned to different groups to evaluate MB-PDT's effectiveness. Some will receive MB-PDT at a patient-specific dose alongside standard abscess drainage, while others will receive MB-PDT at a pre-defined dose with standard drainage. Studies have found that using MB-PDT during abscess drainage is safe and practical. This treatment involves shining a special light on methylene blue, which helps kill the bacteria in the abscess. Early results suggest that the right dose is crucial for optimal effect. Overall, MB-PDT might enhance standard abscess drainage by potentially speeding up recovery. ^{1 2 3 4 6}

Who Is on the Research Team?

Timothy M Baran, PhD

Principal Investigator

University of Rochester

Ashwani K Sharma, MD

Principal Investigator

University of Rochester

Laurie Christensen, BS

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

Adults over 18 with symptoms, lab results, and scans indicating an abscess needing drainage can join. They must be approved by their care team for PDT treatment. Excluded are those with poor kidney function, pregnant or lactating individuals, low platelet counts, bleeding disorders, no safe access to the abscess, inability to consent or follow procedures, large abscesses (>13 cm), allergies to certain substances including contrast media and eggs.

Inclusion Criteria

I have symptoms and test results that suggest I have an abscess needing drainage.

My doctor agrees I can try photodynamic therapy and discuss joining the trial.

Exclusion Criteria

You are allergic to certain substances like contrast media, narcotics, sedatives, atropine, or eggs.

Unable to comply with necessary follow up

I am unable to understand or agree to the study details.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive methylene blue photodynamic therapy (MB-PDT) or standard of care abscess drainage

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including time to removal of the drainage catheter and symptom resolution

14 days

Daily monitoring

Long-term Follow-up

Participants are monitored for long-term abscess resolution and recurrence

Up to 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Methylene Blue Photodynamic Therapy
• Standard of care abscess drainage

Trial Overview

The trial tests Methylene Blue Photodynamic Therapy (MB-PDT) during standard abscess drainage. It has three parts: one uses a fixed MB-PDT dose plus drainage; another tailors the dose based on optical measurements plus drainage; the third only does standard drainage. The main goal is seeing how well each method reduces bacteria in the abscess.

How Is the Trial Designed?

Group I: Standard of care abscess drainage Experimental Treatment 1 Intervention

Each subject in this arm will receive standard of care abscess drainage

Group II: MB-PDT at pre-defined dose plus standard of care abscess drainage Experimental Treatment 5 Interventions

Each subject in this arm will receive standard of care abscess drainage, methylene blue, lipid emulsion, and laser illumination at an optical power defined by their abscess size.

Group III: MB-PDT at patient-specific dose plus standard of care abscess drainage Experimental Treatment 6 Interventions

Each subject in this arm will receive standard of care abscess drainage, methylene blue, lipid emulsion, optical spectroscopy, and laser illumination. The optical power for laser illumination will be determined by their abscess morphology and the results of optical spectroscopy.

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/pii/S1572100024001881

Methylene blue photodynamic therapy of deep tissue ...

MB-PDT at the time of percutaneous abscess drainage was safe and feasible, and optical property measurements showed wide variance between subjects. Previous ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07179003

A Phase 2 Study of Methylene Blue Photodynamic Therapy ...

Based on the success of this Phase 1 clinical trial, the current study aims to assess efficacy of MB-PDT at the time of breast abscess drainage.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10982828/

Safety and Feasibility of Photodynamic Therapy for ...

MB-PDT was a safe and feasible adjunct to image-guided percutaneous abscess drainage. Clinical measures indicated a dose-dependent response to ...

4.

pubs.rsna.org

pubs.rsna.org/doi/abs/10.1148/radiol.232667

Safety and Feasibility of Photodynamic Therapy for ...

Photodynamic therapy with methylene blue performed at the time of percutaneous CT- or US-guided abdominopelvic abscess drainage was safe and feasible, ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37904931/

Results of a first in humans Phase 1 clinical trial - PubMed

Results: MB-PDT at the time of abscess drainage was safe and feasible in all cases, with no evidence of fat embolism due to lipid emulsion or ...

6.

spiedigitallibrary.org

spiedigitallibrary.org/conference-proceedings-of-spie/10860/2506177/Methylene-blue-photodynamic-therapy-for-treatment-of-deep-tissue-abscess/10.1117/12.2506177.full

Methylene blue photodynamic therapy for treatment of ...

We have therefore undertaken a Phase 1 clinical trial to evaluate safety and feasibility of methylene blue mediated photodynamic therapy (MB-PDT) ...