Phage Therapy for the Prevention and Treatment of Wound Infections in Burned Patients

NCT04323475 | Unknown Phase 1 FDA Drug

• 1 other identifier: PGX-18001
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The central aim of this trial is to investigate the safety and tolerability of Phage Cocktail-SPK as an adjunct to standard therapy for the prevention and treatment of burns susceptible to infection/or infected by S. aureus, P. aeruginosa, or K. pneumoniae species. It is hypothesized that no adverse events, clinical abnormalities, or changes in laboratory tests results related to the application of Phage Cocktail SPK Spray will be observed.

Conditions

Wound Infection

Keywords

Burns; Infection; Infection wound; Infection, Bacterial; Infection Pseudomonas Aeruginosa; Infection Staphylococcus Aureus; Infection, Klebsiella pneumoniae; Resistant Infection

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events coded by MedDra

  Safety of Phage cocktail-SPK will be measured by the number and percent of treatment related adverse events

  At least 14 days

• Incidence of treatment discontinuation due to adverse events

  Tolerability of Phage Cocktail-SPK will be measured by the percent premature discontinuation from the study intervention due to treatment emergent Adverse Events

  14 days

Secondary Outcomes (1)

• Assess if Phage Cocktail-SPK can prevent or reduce S. aureus, P. aeruginosa, or K. pneumoniae wound colonization.

  14 days

Other Outcomes (3)

• Determine the effect of Phage Cocktail-SPK treatment on burn wound progression.

  14 days

• Determine the effect of Phage Cocktail-SPK treatment on the sensitivity profiles of S. aureus, P. aeruginosa, or K. pneumoniae present in the wound

  14 days

• Assess the production of phage antibodies

  14 days

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Standard of care consists of Xeroform primary dressing, a Melolin interface and a crepe. Kenacomb will be used for participants with diagnosed or suspected local infections.

Drug: Xeroform

Cocktail-SPK and standard of care

EXPERIMENTAL

The experimental drug consists of Cocktail-SPK used as an adjunct to the standard of care. Standard of care consists of Xeroform primary dressing, a Melolin interface and a crepe. Kenacomb will be used for participants with diagnosed or suspected local infections.

Biological: Bacteriophage cocktail spray; Drug: Xeroform

Interventions

Bacteriophage cocktail spray BIOLOGICAL

Study intervention consists of a dosage-metered airless spray containing a cocktail of 14 bacteriophages at a concentration of 1.4 x 10\^8 PFU/mL for an effective dosage of 2.5 x10\^5 PFU/cm\^2 of burned area. The study intervention will be applied in conjunction with standard of care.

Also known as: PGX-0100, Phage cocktail-SPK

Cocktail-SPK and standard of care

Xeroform DRUG

Standard of care will consist of Xeroform primary dressing and Kenacomb topical antibiotic cream (for wounds with signs of localized infection)

Also known as: Kenacomb

Cocktail-SPK and standard of care; 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 lifestyle considerations, and availability for the duration of the study
• Male or female, aged 18 years or older presenting at the emergency department, out-patient burn department or in-hospital patients with a thermal second degree burn wounds (American Burn Association severity classification).
• Patients with a burn wound covering less than 10% of their total body surface area (TBSA) and present within 7 days of their injury, with or without signs of local infection, expected to heal without the need for surgery.
• 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:

• Current use of dressings containing silver or nanocrystalline silver
• Pregnancy or lactation
• Clinical evidence of invasive infection based on American Burn Association consensus conference(Greenhalgh et al., 2007).
• Burn wounds present in anatomic locations such as burns on the face, hands, feet, genitals, perineum, as well as sites at high risk for developing compartment syndrome (deep circumferential extremity burns).
• Known allergic reactions to components of Xeroform or Kenacomb.
• Patients diagnosed with Type I or Type II diabetes.
• 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 PGX-0100.

Sponsors & Collaborators

• Precisio Biotix Therapeutics, Inc.: lead

MeSH Terms

Conditions

Wound Infection; Burns; Infections; Bacterial Infections; Pseudomonas Infections; Staphylococcal Infections

Interventions

2,4,6-tribromophenol; Gramicidin, Neomycin Sulfate, Nystatin, Triamcinolone Acetonide Drug Combination

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections

Study Officials

• Nancy Tawil, PhD

  Precisio Biotix Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Nancy Tawil, PhD

CONTACT

18002430116; ntawil@phagelux.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 26, 2020
• Study Start: January 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: August 1, 2023
• Last Updated: December 22, 2021

Record last verified: 2021-12