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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | 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. |
|
| Cocktail-SPK and standard of care | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacteriophage cocktail spray | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nancy Tawil, PhD | Contact | 18002430116 | ntawil@phagelux.com |
| Name | Affiliation | Role |
|---|---|---|
| Nancy Tawil, PhD | Precisio Biotix Therapeutics, Inc. | Study Director |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D002056 | Burns |
| D007239 | Infections |
| D001424 | Bacterial Infections |
| D011552 | Pseudomonas Infections |
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001423 | Bacterial Infections and Mycoses |
| D016905 | Gram-Negative Bacterial Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| C004554 | 2,4,6-tribromophenol |
| C014118 | Gramicidin, Neomycin Sulfate, Nystatin, Triamcinolone Acetonide Drug Combination |
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|
|
| Xeroform | Drug | Standard of care will consist of Xeroform primary dressing and Kenacomb topical antibiotic cream (for wounds with signs of localized infection) |
|
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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 |