Wound Infection
Conditions
Keywords
Burns, Infection, Infection wound, Infection, Bacterial, Infection Pseudomonas Aeruginosa, Infection Staphylococcus Aureus, Infection, Klebsiella pneumoniae, Resistant Infection
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.
Interventions
BIOLOGICALBacteriophage 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.
DRUGXeroform
Standard of care will consist of Xeroform primary dressing and Kenacomb topical antibiotic cream (for wounds with signs of localized infection)
Sponsors
Precisio Biotix Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events coded by MedDra | At least 14 days | Safety of Phage cocktail-SPK will be measured by the number and percent of treatment related adverse events |
| Incidence of treatment discontinuation due to adverse events | 14 days | Tolerability of Phage Cocktail-SPK will be measured by the percent premature discontinuation from the study intervention due to treatment emergent Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess if Phage Cocktail-SPK can prevent or reduce S. aureus, P. aeruginosa, or K. pneumoniae wound colonization. | 14 days | Change in the incidence of positive wound cultures for S. aureus, P. aeruginosa, K. pneumoniae; |
Other
| Measure | Time frame | Description |
|---|---|---|
| Determine the effect of Phage Cocktail-SPK treatment on burn wound progression. | 14 days | Rate of wound re-epithelization by visual judgment and burn depth and progression by photography. |
| 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 | Change in antibiotic and phage sensitivity profile of S. aureus, P. aeruginosa, K. pneumoniae. |
| Assess the production of phage antibodies | 14 days | Presence of Phage Cocktail-SPK antibodies in serum samples |
Contacts
Primary ContactNancy Tawil, PhD
Outcome results
None listed