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

Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04323475
• Other study ID #: PGX-18001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 2022
• Est. completion date: August 2023

Study information

• Verified date: December 2021
• Source: Phagelux Inc.
• Contact: Nancy Tawil, PhD
• Phone: 18002430116
• Email: ntawil[@]phagelux.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: August 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Wound Infection
• Wounds and Injuries

Intervention

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.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Phagelux Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Assess the production of phage antibodies	Presence of Phage Cocktail-SPK antibodies in serum samples	14 days
Primary	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
Primary	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	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