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

A Randomized, Open-Label, Active Controlled Study to Evaluate the Safety and Tolerability of a Phage Cocktail-SPK Therapy in Second Degree Burn Wounds in Adult Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Infection
• Intervention / Treatment: Drug: Xeroform; Biological: Bacteriophage cocktail spray

Detailed Description

This is a Phase I, randomized, open-label, active controlled study to evaluate the safety and tolerability of a Phage Cocktail-SPK therapy for second degree burn wounds in adult patients. The wound will be clinically selected on the basis that it is a second degree burn less than 10 percent of total body surface area, and that, according to medical assessment, should heal without surgical intervention. The study is intended to include one site outside of the United States of America, namely the Royal Brisbane and Women's Hospital, in Brisbane, Queensland, Australia.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Nancy Tawil, PhD; Phone Number: 18002430116; Email: ntawil@phagelux.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and lifestyle considerations, and availability for the duration of the study
3. 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).
4. 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.
5. 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
6. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:

1. Current use of dressings containing silver or nanocrystalline silver
2. Pregnancy or lactation
3. Clinical evidence of invasive infection based on American Burn Association consensus conference(Greenhalgh et al., 2007).
4. 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).
5. Known allergic reactions to components of Xeroform or Kenacomb.
6. Patients diagnosed with Type I or Type II diabetes.
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 PGX-0100.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Xeroform; Standard of care will consist of Xeroform primary dressing and Kenacomb topical antibiotic cream (for wounds with signs of localized infection); Other Names: Kenacomb
Experimental: Cocktail-SPK and standard of care; 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.	Drug: Xeroform; Standard of care will consist of Xeroform primary dressing and Kenacomb topical antibiotic cream (for wounds with signs of localized infection); Other Names: Kenacomb; Biological: Bacteriophage cocktail spray; 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.; Other Names: PGX-0100; Phage cocktail-SPK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess if Phage Cocktail-SPK can prevent or reduce S. aureus, P. aeruginosa, or K. pneumoniae wound colonization.	Change in the incidence of positive wound cultures for S. aureus, P. aeruginosa, K. pneumoniae;	14 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the effect of Phage Cocktail-SPK treatment on burn wound progression.	Rate of wound re-epithelization by visual judgment and burn depth and progression by photography.	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	Change in antibiotic and phage sensitivity profile of S. aureus, P. aeruginosa, K. pneumoniae.	14 days
Assess the production of phage antibodies	Presence of Phage Cocktail-SPK antibodies in serum samples	14 days

Collaborators and Investigators

• Sponsor: Phagelux Inc.
• Investigators: Study Director: Nancy Tawil, PhD, Phagelux Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: March 20, 2020
• First Submitted That Met QC Criteria: March 24, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Infection; Burns; Resistant Infection; Infection wound; Infection, Bacterial; Infection Pseudomonas Aeruginosa; Infection Staphylococcus Aureus; Infection, Klebsiella pneumoniae
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: PGX-18001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No