Wound InfectionPhase 1NCT04323475
Phage Therapy for the Prevention and Treatment of Wound Infections in Burned Patients
A Phase 1 study testing Bacteriophage cocktail spray and Xeroform in people with Wound Infection, run by Precisio Biotix Therapeutics, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection
- What is being tested?
- Bacteriophage cocktail spray and Xeroform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Wound Infection
- Being tested
- Bacteriophage cocktail spray, Xeroform
- Keywords
- Burns, Infection, Infection wound, Infection, Bacterial, Infection Pseudomonas Aeruginosa, Infection Staphylococcus Aureus, Infection, Klebsiella pneumoniae, Resistant Infection
- Medical subject headings
- Wound Infection, Burns, Infections, Bacterial Infections, Pseudomonas Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriophage cocktail sprayBiological
Also called PGX-0100, Phage cocktail-SPK
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.
XeroformDrug
Also called Kenacomb
Standard of care will consist of Xeroform primary dressing and Kenacomb topical antibiotic cream (for wounds with signs of localized infection)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Xeroform |
| 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. Receives: Biological: Bacteriophage cocktail spray; Drug: Xeroform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 14 days
Secondary outcomes (1)
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;
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study startJan 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Precisio Biotix Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Tawil, PhD, Study director, Precisio Biotix Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323475
- Sponsor's protocol ID
- PGX-18001
- Status last verified
- Dec 2021
- First submitted
- 20 Mar 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04323475
- Acronym / sponsor ID
- PGX-18001
- Conditions
- Wound Infection
- Keywords
- Burns, Infection, Infection wound, Infection, Bacterial, Infection Pseudomonas Aeruginosa, Infection Staphylococcus Aureus, Infection, Klebsiella pneumoniae, Resistant Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Precisio Biotix Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Drug: XeroformStandard 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 | Biological: Bacteriophage cocktail spray, Drug: XeroformThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacteriophage cocktail sprayAlso: PGX-0100, Phage cocktail-SPKStudy 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. | Biological | Cocktail-SPK and standard of care |
| XeroformAlso: KenacombStandard of care will consist of Xeroform primary dressing and Kenacomb topical antibiotic cream (for wounds with signs of localized infection) | Drug | Cocktail-SPK and standard of care, Standard of Care |
Primary outcome
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
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
1 secondary outcome
Assess if Phage Cocktail-SPK can prevent or reduce S. aureus, P. aeruginosa, or K. pneumoniae wound colonization.
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Tawil, PhD study director
Precisio Biotix Therapeutics, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bacteriophage cocktail spray and Xeroform in people with Wound Infection, run by Precisio Biotix Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nancy Tawil, PhD (18002430116, ntawil@phagelux.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events coded by MedDra (time frame: At least 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.