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Procedure

Photodynamic Therapy for Abscess

Phase 2

Waitlist Available

Led By Timothy M Baran, PhD

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All patients with clinical symptoms (ex: fever, chills, pain, tachycardia, hypotension), laboratory (leukocytosis) and radiologic findings (thick walled, rim-enhancing collection with gas bubbles or air-fluid levels) compatible with an abscess that requires image-guided percutaneous drainage

Be older than 18 years old

Must not have

Unable or unwilling to understand or to provide informed consent

Necrotic tissue that requires surgical debridement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre and post intervention (approximately 24 hours)

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate a light+drug treatment to reduce bacterial burden in deep tissue abscesses at the time of drainage. 3 arms: light+drug+drainage, light+drug+optical measurements+drainage, or just drainage. Primary endpoint is reduction in bacterial burden.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of MB-PDT may include reactions at the site of treatment such as pain or swelling, sensitivity to light due to methylene blue exposure (photosensitivity), and general discomfort from laser illumination.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I need surgery to remove dead tissue.

Select...

My heart and lung function is severely impaired.

Select...

I have an abscess larger than 13 cm.

Select...

My kidney function is poor (creatinine >3mg/dl).

Select...

I have a blood clotting disorder that cannot be corrected.

Select...

Doctors cannot safely reach the abscess or fluid in my body.

Select...

I cannot stay still or be positioned for the procedure due to my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre and post intervention (approximately 24 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre and post intervention (approximately 24 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre and post intervention (approximately 24 hours) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Change in bacterial burden

Secondary study objectives

Mean Change in white blood cell count

Total volume of catheter drainage output

mean number of days from intervention to symptom resolution

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Standard of care abscess drainageExperimental Treatment1 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 drainageExperimental Treatment5 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 drainageExperimental Treatment6 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lipid Emulsion

2015

Completed Phase 4

~40

Methylene Blue

2021

Completed Phase 4

~1530