Clinical trial NCT04815798: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pressure Ulcer
Keywords: Wound infection
Pressure injury
Bedsores
Pseudomonas aeruginosa
Klebsiella pneumoniae
Staphylococcus aureus
Resistant infection
Phage
Bacteriophage
Lead sponsor: Precisio Biotix Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events coded by MedDra
timeFrame: At least 56 days
measure: Incidence of treatment discontinuation due to adverse events
timeFrame: 56 days
Secondary outcomes:
measure: Assess if BACTELIDE can improve the clinical outcome by preventing or treating wound infection.
timeFrame: 28 days
measure: Assess the effect of BACTELIDE on the incidence of bacterial colonization by S. aureus, P. aeruginosa, or K. pneumoniae species in pressure injury wounds.
timeFrame: 28 days
measure: Assess the effect of BACTELIDE on the rate of wound progression.
timeFrame: 56 days
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Gina Suh, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Miami Veterans Affairs Healthcare System
name: Karin Zachow, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Miami University Health System
name: Hector Bolivar, M.D.
role: PRINCIPAL_INVESTIGATOR
References: