Phage Therapy for the Prevention and Treatment of Pressure Ulcers.

A Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Potential Efficacy of BACTELIDE vs. Placebo in Addition to Standard-of-care Therapy for S. Aureus, P. Aeruginosa, and K. Pneumoniae Colonized Pressure Injuries

This study will evaluate a topical bacteriophage therapy product (BACTELIDE) as an adjunct to standard therapy for the prevention and treatment of pressure ulcers colonized with S. aureus, P. aeruginosa, or K. pneumoniae species.

This study will compare the safety and efficacy of BACTELIDE in conjunction with standard of care (SOC) versus a placebo in conjunction with standard of care.

Study Overview

• Status: Not yet recruiting
• Conditions: Pressure Ulcer
• Intervention / Treatment: Combination product: Bacteriophage-loaded Microcapsule Spray; Procedure: Standard of Care; Combination product: Placebo

Detailed Description

The central aim of this study is to investigate the safety, tolerability, and indicative efficacy of a single dose of a phage therapy combination product, BACTELIDE, as an adjunct to standard therapy in participants presenting with a Stage II, III or IV pressure injuries with positive wound cultures for S. aureus, P. aeruginosa, or K. pneumoniae at screening.

• Study Type: Interventional
• Enrollment (Anticipated): 69
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Nancy Tawil, Ph.D.; Phone Number: 1-800-243-0116; Email: Nancy.tawil@phageluxcanada.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Stated willingness to comply with lifestyle considerations
4. Male or female, 18 years or older presenting in long-term care facilities, out-patient department or in-hospital patients with a stage II, III or IV pressure injury with or without local signs of infection with a size not exceeding 28 cm2
5. Within 72 hours before randomization, pressure injury specimen positive for S. aureus, P. aeruginosa, or K. pneumoniae determined by qPCR or rapid diagnostic test or conventional method or positive growth on specific agar.
6. For females of reproductive potential: use of a highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of administration of the study intervention
7. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

Exclusion Criteria:

1. Diagnosis of Kennedy terminal ulcer, Trombley-Brennan terminal tissue injuries or skin changes at life's end (SCALE).
2. Pregnancy or lactation.
3. Known allergic reactions to components of SilvaSorb hydrogel.
4. Known allergic reactions to components of the phage treatment; including known allergic reactions to bacteriophages, polyester amide urea polymers and/or TMN buffer.
5. Unstable coronary artery disease.
6. Patients diagnosed with Type I or Type II diabetes, uncontrolled (HgbA1c >8% or 2+ glycosuria).
7. Treatment with another investigational drug or other intervention within 30 days.
8. Intercurrent condition requiring a high dose of chronic corticosteroid therapy, immunosuppressive medication, oncologic chemotherapy.
9. Patients who have additional uncontrolled serious medical or psychiatric illness determined by the investigators where the patient is unfit to receive the product.
10. Chronic stool incontinence without a rectal tube if an individual has a sacral ulcer.
11. Placement of a wound vacuum.
12. Surgical wound closure planned within the study period.
13. Organ failure, acute respiratory failure and chronic renal failure.
14. Diagnosed osteomyelitis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bacteriophage-loaded Microcapsule Spray with Standard of Care; Phage therapy (Bacteriophage-loaded Microcapsule Spray) will be administered topically in conjunction with standard of care for pressure ulcers.	Combination product: Bacteriophage-loaded Microcapsule Spray; Study intervention consists of a dosage-metered airless spray containing a cocktail of 14 bacteriophages encapsulated in a biodegradable polymer. This bacteriophage product will be delivered topically every 3 days for 56 days or until wound has healed.; Other Names: BACTELIDE; PL-03-BM; Procedure: Standard of Care; Standard of care consists of but is not limited to offloading, positioning, cleansing, debridement, and wound dressing. A topical antimicrobial hydrogel will applied to wounds with signs of localized infection.
PLACEBO_COMPARATOR: Placebo with Standard of Care; Placebo, analogous to the experimental arm, will be administered topically in conjunction with standard of care for pressure ulcers.	Procedure: Standard of Care; Standard of care consists of but is not limited to offloading, positioning, cleansing, debridement, and wound dressing. A topical antimicrobial hydrogel will applied to wounds with signs of localized infection.; Combination product: Placebo; Placebo intervention consists of a dosage-metered airless spray containing a buffer solution analogous to the study intervention. This placebo will be delivered topically every 3 days for 56 days or until wound has healed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events coded by MedDra	Safety of BACTELIDE will be measured by the number and percent of treatment related adverse events.	At least 56 days
Incidence of treatment discontinuation due to adverse events	Tolerability of BACTELIDE will be measured by the percent premature discontinuation from the study intervention due to treatment emergent Adverse Events	56 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess if BACTELIDE can improve the clinical outcome by preventing or treating wound infection.	Response/improvement in treatment-specific clinical outcome based on change in PUSH tool scores.	28 days
Assess the effect of BACTELIDE on the incidence of bacterial colonization by S. aureus, P. aeruginosa, or K. pneumoniae species in pressure injury wounds.	Change in the incidence of positive wound cultures for S. aureus, P. aeruginosa, K. pneumoniae collected from surface deep wound swabs and /or tissue specimens.	28 days
Assess the effect of BACTELIDE on the rate of wound progression.	Rate of wound progression will be measured by change in viable tissue.	56 days

Collaborators and Investigators

• Sponsor: Phagelux Inc.
• Investigators: Principal Investigator: Gina Suh, M.D., Mayo Clinic; Principal Investigator: Karin Zachow, M.D., Miami Veterans Affairs Healthcare System; Principal Investigator: Hector Bolivar, M.D., Miami University Health System

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (ACTUAL): March 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Staphylococcus aureus; Pressure injury; Wound infection; Pseudomonas aeruginosa; Klebsiella pneumoniae; Bacteriophage; Phage; Bedsores; Resistant infection
• Additional Relevant MeSH Terms: Skin Diseases; Skin Ulcer; Pressure Ulcer
• Other Study ID Numbers: PGX-20001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No