Clinical trial NCT04323475: Phage Therapy for the Prevention and Treatment of Wound Infections in Burned Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Wound Infection
Keywords: Burns
Infection
Infection wound
Infection, Bacterial
Infection Pseudomonas Aeruginosa
Infection Staphylococcus Aureus
Infection, Klebsiella pneumoniae
Resistant Infection
Lead sponsor: Precisio Biotix Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events coded by MedDra
timeFrame: At least 14 days
measure: Incidence of treatment discontinuation due to adverse events
timeFrame: 14 days
Secondary outcomes:
measure: Assess if Phage Cocktail-SPK can prevent or reduce S. aureus, P. aeruginosa, or K. pneumoniae wound colonization.
timeFrame: 14 days
Other outcomes:
measure: Determine the effect of Phage Cocktail-SPK treatment on burn wound progression.
timeFrame: 14 days
measure: Determine the effect of Phage Cocktail-SPK treatment on the sensitivity profiles of S. aureus, P. aeruginosa, or K. pneumoniae present in the wound
timeFrame: 14 days
measure: Assess the production of phage antibodies
timeFrame: 14 days
Locations:
Study officials:
affiliation: Precisio Biotix Therapeutics, Inc.
name: Nancy Tawil, PhD
role: STUDY_DIRECTOR
References: