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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04323475




Registration number
NCT04323475
Ethics application status
Date submitted
20/03/2020
Date registered
26/03/2020
Date last updated
26/03/2020

Titles & IDs
Public title
Phage Therapy for the Prevention and Treatment of Wound Infections in Burned Patients
Scientific 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
Secondary ID [1] 0 0
PGX-18001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Bacteriophage cocktail spray
Treatment: Drugs - Xeroform

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.

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.


Other interventions: 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.

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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
At least 14 days
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
14 days
Secondary outcome [1] 0 0
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;
Timepoint [1] 0 0
14 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4029 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Phagelux Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04323475
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jason Brown, MD
Address 0 0
Royal Brisbane and Women's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nancy Tawil, PhD
Address 0 0
Country 0 0
Phone 0 0
18002430116
Fax 0 0
Email 0 0
ntawil@phagelux.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04323475