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

NCT ID: NCT04323475

Last Updated: 2021-12-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2023-08-31

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.

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.

Conditions

Wound Infection

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Xeroform

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Bacteriophage cocktail spray

Intervention Type: 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.

Xeroform

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: BIOLOGICAL

Xeroform

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

Intervention Type: DRUG

Other Intervention Names

PGX-0100; Phage cocktail-SPK; Kenacomb

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Precisio Biotix Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy Tawil, PhD

Role: STUDY_DIRECTOR

Precisio Biotix Therapeutics, Inc.

Countries

Australia

Central Contacts

Nancy Tawil, PhD

Role: CONTACT

Phone: 18002430116

Email: ntawil@phagelux.com

Other Identifiers

PGX-18001

Identifier Type: -

Identifier Source: org_study_id