NCT04323475

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Precisio Biotix Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-01-01
• Completion: 2023-08-01
• First posted: 2020-03-26
• Last updated: 2021-12-22

Regulatory

• FDA-regulated drug study