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Procedure

Photodynamic Therapy for Abscess

Phase 2

Waitlist Available

Led By Ashwani K Sharma, MD

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre and post intervention (approximately 24 hours)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Change in bacterial burden

Secondary outcome measures

Mean Change in white blood cell count

Total volume of catheter drainage output

mean number of days from intervention to symptom resolution

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

~1390

Insertion of optical fiber

2014

Completed Phase 1

~30

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor

837 Previous Clinical Trials

518,057 Total Patients Enrolled

1 Trials studying Abscess

21 Patients Enrolled for Abscess

Maria D Favella, BSStudy DirectorUniversity of Rochester

Laurie Christensen, BSStudy DirectorUniversity of Rochester

1 Previous Clinical Trials

21 Total Patients Enrolled

1 Trials studying Abscess

21 Patients Enrolled for Abscess

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts currently active for this research?

"According to the data on clinicaltrials.gov, this particular medical trial is not currently looking for participants. This research project was originally posted on May 1st 2024 and most recently amended on September 18th 2023. That being said, there are still eighteen other trials actively recruiting individuals at this moment in time."

Answered by AI

Is the combination of MB-PDT at a pre-defined dose in conjunction with conventional abscess drainage approved by the FDA?

"Given the Phase 2 status of this trial, our team has allocated a score of two to MB-PDT's safety in combination with standard abscess drainage. There is evidence that suggests it is safe but none yet indicating its effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses

Timothy Baran 2024. "Efficacy of Methylene Blue Photodynamic Therapy for Treatment of Deep Tissue Abscesses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052956.

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