Status:
UNKNOWN
Phage Therapy for the Prevention and Treatment of Wound Infections in Burned Patients
Lead Sponsor:
Precisio Biotix Therapeutics, Inc.
Conditions:
Wound Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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/o...
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 wi...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and lifestyle considerations, and availability for the duration of the study
- 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).
- 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.
- 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
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner
Exclusion
- Current use of dressings containing silver or nanocrystalline silver
- Pregnancy or lactation
- Clinical evidence of invasive infection based on American Burn Association consensus conference(Greenhalgh et al., 2007).
- 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).
- Known allergic reactions to components of Xeroform or Kenacomb.
- Patients diagnosed with Type I or Type II diabetes.
- Treatment with another investigational drug or other intervention within 30 days
- Intercurrent condition requiring a high dose of chronic corticosteroid therapy, immunosuppressive medication, oncologic chemotherapy.
- Patients who have additional uncontrolled serious medical or psychiatric illness determined by the investigators where the patient is unfit to receive PGX-0100.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04323475
Start Date
January 1 2022
End Date
August 1 2023
Last Update
December 22 2021
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