Phage Therapy for the Prevention and Treatment of Pressure Ulcers.

NCT04815798 | Unknown Phase 1 FDA Drug

• 1 other identifier: PGX-20001
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pressure Ulcer

Keywords

Wound infection; Pressure injury; Bedsores; Pseudomonas aeruginosa; Klebsiella pneumoniae; Staphylococcus aureus; Resistant infection; Phage; Bacteriophage

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Assess if BACTELIDE can improve the clinical outcome by preventing or treating wound infection.

  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.

  28 days

• Assess the effect of BACTELIDE on the rate of wound progression.

  56 days

Study Arms (2)

Bacteriophage-loaded Microcapsule Spray with Standard of Care

EXPERIMENTAL

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; Procedure: Standard of Care

Placebo with Standard of Care

PLACEBO COMPARATOR

Placebo, analogous to the experimental arm, will be administered topically in conjunction with standard of care for pressure ulcers.

Combination Product: Placebo; Procedure: Standard of Care

Interventions

Bacteriophage-loaded Microcapsule Spray COMBINATION_PRODUCT

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.

Also known as: BACTELIDE, PL-03-BM

Bacteriophage-loaded Microcapsule Spray with Standard of Care

Placebo COMBINATION_PRODUCT

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.

Placebo with Standard of Care

Standard of Care PROCEDURE

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.

Bacteriophage-loaded Microcapsule Spray with Standard of Care; Placebo with Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Stated willingness to comply with lifestyle considerations
• 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
• 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.
• 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
• For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.

You may not qualify if:

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

Sponsors & Collaborators

• Precisio Biotix Therapeutics, Inc.: lead

MeSH Terms

Conditions

Pressure Ulcer; Wound Infection; Pseudomonas Infections; Staphylococcal Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Tawil, Ph.D.

CONTACT

1-800-243-0116; Nancy.tawil@phageluxcanada.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 25, 2021
• Study Start: January 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 21, 2021

Record last verified: 2021-12