Pressure UlcerPhase 1/2NCT04815798
Phage Therapy for the Prevention and Treatment of Pressure Ulcers.
A Phase 1/2 study testing Bacteriophage-loaded Microcapsule Spray in people with Pressure Ulcer, run by Precisio Biotix Therapeutics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Bacteriophage-loaded Microcapsule Spray
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Pressure Ulcer
- Being tested
- Bacteriophage-loaded Microcapsule Spray, Placebo, Standard of Care
- Keywords
- Wound infection, Pressure injury, Bedsores, Pseudomonas aeruginosa, Klebsiella pneumoniae, Staphylococcus aureus, Resistant infection, Phage, Bacteriophage
- Medical subject headings
- Pressure Ulcer, Wound Infection, Pseudomonas Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriophage-loaded Microcapsule SprayCombination product
Also called BACTELIDE, PL-03-BM
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.
PlaceboCombination 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.
Standard of CareProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Placebo; Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 56 days
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study startJan 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precisio Biotix Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gina Suh, M.D., Principal investigator, Mayo ClinicKarin Zachow, M.D., Principal investigator, Miami Veterans Affairs Healthcare SystemHector Bolivar, M.D., Principal investigator, Miami University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815798
- Sponsor's protocol ID
- PGX-20001
- Status last verified
- Dec 2021
- First submitted
- 19 Mar 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04815798
- Acronym / sponsor ID
- PGX-20001
- Conditions
- Pressure Ulcer
- Keywords
- Wound infection, Pressure injury, Bedsores, Pseudomonas aeruginosa, Klebsiella pneumoniae, Staphylococcus aureus, Resistant infection, Phage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Precisio Biotix Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacteriophage-loaded Microcapsule Spray with Standard of Care | Experimental | Combination Product: Bacteriophage-loaded Microcapsule Spray, Procedure: Standard of CarePhage therapy (Bacteriophage-loaded Microcapsule Spray) will be administered topically in conjunction with standard of care for pressure ulcers. |
| Placebo with Standard of Care | Placebo comparator | Combination Product: Placebo, Procedure: Standard of CarePlacebo, analogous to the experimental arm, will be administered topically in conjunction with standard of care for pressure ulcers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacteriophage-loaded Microcapsule SprayAlso: BACTELIDE, PL-03-BMStudy 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. | Combination product | Bacteriophage-loaded Microcapsule Spray with Standard of Care |
| PlaceboPlacebo 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. | Combination product | Placebo with Standard of Care |
| Standard of CareStandard 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. | Procedure or surgery | Bacteriophage-loaded Microcapsule Spray with Standard of Care, Placebo with Standard of Care |
Primary outcome
Incidence of Treatment-Emergent Adverse Events coded by MedDra
Time frame: At least 56 days
Safety of BACTELIDE will be measured by the number and percent of treatment related adverse events.
Incidence of treatment discontinuation due to adverse events
Time frame: 56 days
Tolerability of BACTELIDE will be measured by the percent premature discontinuation from the study intervention due to treatment emergent Adverse Events
3 secondary outcomes
Assess if BACTELIDE can improve the clinical outcome by preventing or treating wound infection.
Time frame: 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.
Time frame: 28 days
Assess the effect of BACTELIDE on the rate of wound progression.
Time frame: 56 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Suh, M.D. principal investigator
Mayo Clinic
Karin Zachow, M.D. principal investigator
Miami Veterans Affairs Healthcare System
Hector Bolivar, M.D. principal investigator
Miami University Health System
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bacteriophage-loaded Microcapsule Spray in people with Pressure Ulcer, run by Precisio Biotix Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy Tawil, Ph.D. (1-800-243-0116, Nancy.tawil@phageluxcanada.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events coded by MedDra (time frame: At least 56 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.