Photodynamic Therapy for Abscess

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

90 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous abscess drainage for disinfection of deep tissue abscesses. The study includes three arms: (1) MB-PDT at a fixed drug/light dose plus standard of care abscess drainage , (2) MB-PDT at a patient-specific dose determined by pre-treatment optical measurements plus standard of care abscess drainage , and (3) standard of care abscess drainage. The primary endpoint is reduction in time to removal of the drainage catheter.

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.

What data supports the effectiveness of the treatment Methylene Blue Photodynamic Therapy for abscesses?

Research shows that photodynamic therapy (PDT) using methylene blue is effective in killing bacteria in abscesses and other infections, including drug-resistant ones. Studies have demonstrated that PDT can be tailored to individual patients, improving its effectiveness in treating abscess cavities. ^{1 2 3 4 5}

How is methylene blue photodynamic therapy different from other treatments for abscesses?

Methylene blue photodynamic therapy (MB-PDT) is unique because it uses a special dye (methylene blue) and light to kill bacteria in abscesses, which is different from traditional methods like antibiotics or surgical drainage. This approach can target drug-resistant bacteria and is being explored for its effectiveness in deep tissue infections. ^{1 2 5 6 7}

Research Team

Laurie Christensen, BS

Principal Investigator

University of Rochester

Ashwani K Sharma, MD

Principal Investigator

University of Rochester

Timothy M Baran, PhD

Principal Investigator

University of Rochester

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Photodynamic therapy of deep tissue abscess cavities: Retrospective image-based feasibility study using Monte Carlo simulation. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of patient-specific treatment planning on eligibility for photodynamic therapy of deep tissue abscess cavities: retrospective Monte Carlo simulation study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment planning for photodynamic therapy of abscess cavities using patient-specific optical properties measured prior to illumination. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

First in human measurements of abscess cavity optical properties and methylene blue uptake prior to photodynamic therapy by in vivo diffuse reflectance spectroscopy. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Application of antimicrobial photodynamic therapy to treat subgingival multidrug-resistant bacterial infections in ICU patients. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

In vitro study of the effect of ALA-PDT on Mycobacterium abscessus and its antibiotic susceptibility. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Methylene blue photodynamic therapy of bacterial species found in human abscesses: Planktonic, biofilm, and 3D silicone models. [2023]