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Phage Therapy for the Prevention and Treatment of Wound Infections in Burned Patients

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ClinicalTrials.gov Identifier: NCT04323475
Recruitment Status : Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : December 22, 2021
Sponsor:
Information provided by (Responsible Party):
Phagelux Inc.

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.

Condition or disease Intervention/treatment Phase
Wound Infection Biological: Bacteriophage cocktail spray Drug: Xeroform Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: Xeroform
Standard of care will consist of Xeroform primary dressing and Kenacomb topical antibiotic cream (for wounds with signs of localized infection)
Other Name: Kenacomb

Experimental: Cocktail-SPK and standard of care
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.
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.
Other Names:
  • PGX-0100
  • Phage cocktail-SPK

Drug: Xeroform
Standard of care will consist of Xeroform primary dressing and Kenacomb topical antibiotic cream (for wounds with signs of localized infection)
Other Name: Kenacomb




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events coded by MedDra [ Time Frame: At least 14 days ]
    Safety of Phage cocktail-SPK will be measured by the number and percent of treatment related adverse events

  2. Incidence of treatment discontinuation due to adverse events [ Time Frame: 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 Outcome Measures :
  1. Assess if Phage Cocktail-SPK can prevent or reduce S. aureus, P. aeruginosa, or K. pneumoniae wound colonization. [ Time Frame: 14 days ]
    Change in the incidence of positive wound cultures for S. aureus, P. aeruginosa, K. pneumoniae;


Other Outcome Measures:
  1. Determine the effect of Phage Cocktail-SPK treatment on burn wound progression. [ Time Frame: 14 days ]
    Rate of wound re-epithelization by visual judgment and burn depth and progression by photography.

  2. Determine the effect of Phage Cocktail-SPK treatment on the sensitivity profiles of S. aureus, P. aeruginosa, or K. pneumoniae present in the wound [ Time Frame: 14 days ]
    Change in antibiotic and phage sensitivity profile of S. aureus, P. aeruginosa, K. pneumoniae.

  3. Assess the production of phage antibodies [ Time Frame: 14 days ]
    Presence of Phage Cocktail-SPK antibodies in serum samples



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323475


Contacts
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Contact: Nancy Tawil, PhD 18002430116 ntawil@phagelux.com

Sponsors and Collaborators
Phagelux Inc.
Investigators
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Study Director: Nancy Tawil, PhD Phagelux Inc.
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Responsible Party: Phagelux Inc.
ClinicalTrials.gov Identifier: NCT04323475    
Other Study ID Numbers: PGX-18001
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: December 22, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Phagelux Inc.:
Burns
Infection
Infection wound
Infection, Bacterial
Infection Pseudomonas Aeruginosa
Infection Staphylococcus Aureus
Infection, Klebsiella pneumoniae
Resistant Infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Wound Infection
Wounds and Injuries
Disease Attributes
Pathologic Processes