Back to resultsPhage Therapy for the Prevention and Treatment of Pressure Ulcers.
Primary Purpose
Pressure Ulcer
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Bacteriophage-loaded Microcapsule Spray
Placebo
Standard of Care
Sponsored by
About this trial
This is an interventional treatment trial for Pressure Ulcer focused on measuring Wound infection, Pressure injury, Bedsores, Pseudomonas aeruginosa, Klebsiella pneumoniae, Staphylococcus aureus, Resistant infection, Phage, Bacteriophage
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Bacteriophage-loaded Microcapsule Spray with Standard of Care
Placebo with Standard of Care
Arm Description
Phage therapy (Bacteriophage-loaded Microcapsule Spray) will be administered topically in conjunction with standard of care for pressure ulcers.
Placebo, analogous to the experimental arm, will be administered topically in conjunction with standard of care for pressure ulcers.
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
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.
Assess the effect of BACTELIDE on the rate of wound progression.
Rate of wound progression will be measured by change in viable tissue.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04815798
Brief Title
Phage Therapy for the Prevention and Treatment of Pressure Ulcers.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Phagelux Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Wound infection, Pressure injury, Bedsores, Pseudomonas aeruginosa, Klebsiella pneumoniae, Staphylococcus aureus, Resistant infection, Phage, Bacteriophage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bacteriophage-loaded Microcapsule Spray with Standard of Care
Arm Type
Experimental
Arm Description
Phage therapy (Bacteriophage-loaded Microcapsule Spray) will be administered topically in conjunction with standard of care for pressure ulcers.
Arm Title
Placebo with Standard of Care
Arm Type
Placebo Comparator
Arm Description
Placebo, analogous to the experimental arm, will be administered topically in conjunction with standard of care for pressure ulcers.
Intervention Type
Combination Product
Intervention Name(s)
Bacteriophage-loaded Microcapsule Spray
Other Intervention Name(s)
BACTELIDE, PL-03-BM
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard of Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events coded by MedDra
Description
Safety of BACTELIDE will be measured by the number and percent of treatment related adverse events.
Time Frame
At least 56 days
Title
Incidence of treatment discontinuation due to adverse events
Description
Tolerability of BACTELIDE will be measured by the percent premature discontinuation from the study intervention due to treatment emergent Adverse Events
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Assess if BACTELIDE can improve the clinical outcome by preventing or treating wound infection.
Description
Response/improvement in treatment-specific clinical outcome based on change in PUSH tool scores.
Time Frame
28 days
Title
Assess the effect of BACTELIDE on the incidence of bacterial colonization by S. aureus, P. aeruginosa, or K. pneumoniae species in pressure injury wounds.
Description
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.
Time Frame
28 days
Title
Assess the effect of BACTELIDE on the rate of wound progression.
Description
Rate of wound progression will be measured by change in viable tissue.
Time Frame
56 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Tawil, Ph.D.
Phone
1-800-243-0116
Email
Nancy.tawil@phageluxcanada.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina Suh, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karin Zachow, M.D.
Organizational Affiliation
Miami Veterans Affairs Healthcare System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hector Bolivar, M.D.
Organizational Affiliation
Miami University Health System
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Phage Therapy for the Prevention and Treatment of Pressure Ulcers.
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