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Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection (REVERSE2)

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ClinicalTrials.gov Identifier: NCT05948592
Recruitment Status : Recruiting
First Posted : July 17, 2023
Last Update Posted : April 11, 2024
Sponsor:
Collaborator:
VectorB2B
Information provided by (Responsible Party):
Technophage, SA

Study Description
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Brief Summary:
TP-102 is a novel bacteriophage cocktail comprised of 5 (five) lytic bacteriophages against Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii. TP-102 is being developed for topical treatment of patients with wound infections including chronic ulcers; applied every other day (three times weekly (TIW)).

Condition or disease Intervention/treatment Phase
Diabetic Foot Infection Biological: TP-102 Other: Placebo Phase 2

Detailed Description:

This is a Phase 2b, double-blinded, randomised, placebo-controlled multicenter study to determine the safety and efficacy of TP-102, in patients with diabetic foot infection.

Eighty (80) patients with an infected diabetic foot ulcer and with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii) susceptible to TP-102.

Patients will be randomised to receive TP-102 or placebo, in a 1:1 ratio. Patients will be treated with 1 (one) mL of IP/ Placebo solution applied topically per cm3 of target ulcer. Patients will be treated with a total of 12 treatments in 28 days (+3 days) with at least one day of interval in between the days of treatment (no consecutive days of treatment are allowed) and a maximum of 3 (three) days without treatment.

The titre of each bacteriophage in TP-102 is 1x109 (>1x108 and < 1x1010) plaque forming units per milliliter (PFU/mL).

Assessments for efficacy and safety will include concomitant medications and AEs, local tolerability, clinical laboratory tests, vital signs, physical examination, wound biopsy/swab to determine the presence, speciation and TP-102 sensitivity of bacteria and target ulcer assessment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 CT to Evaluate the Safety and Efficacy of Topical Administration of Bacteriophage Therapy TP-102 in Patients With DFI
Actual Study Start Date : November 8, 2023
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TP-102
Patients will be randomly assigned in a 1:1 ratio to one of two treatment arms at Day 1. The wound standard of care (SoC) procedures shall be in accordance to each sites normal DFI routine.
 Biological: TP-102
Patients randomised to TP-102 will receive 1 (one) mL of IP solution, applied topically per cm3 of target ulcer. The titre of each bacteriophage in TP-102 is 1x109 PFU/mL (>1x108 PFU/mL and <1x1010 PFU/mL). All patients randomised to TP-102 will receive the same concentration per mL. TP-102 will be applied to the target ulcer using a syringe without a needle. The volume of TP-102 to be administered will be determined from the wound volume assessment at the previous visit through an automated wound measurement system (Silhouette), except on the first day of treatment where the amount applied will be determined based on the wound volume determined at that time using the automated wound measurement system (Silhouette).
Placebo Comparator: Placebo
Patients will be randomly assigned in a 1:1 ratio to one of two treatment arms at Day 1. The wound standard of care (SoC) procedures shall be in accordance to each sites normal DFI routine.
 Other: Placebo
Patients randomised to placebo, the volume calculated to be administered will be determined from the wound volume assessment at the previous visit through an automated wound measurement system (Silhouette), except on the first day of treatment where the amount applied will be determined based on the wound volume determined at that time using the automated wound measurement system (Silhouette).


Outcome Measures
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Primary Outcome Measures :
  1. 1. Number and percentage of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline to EOT, aproximately 12 weeks ]
    See above

  2. 2. Mean DFUWI score (total AUC) for TP-102 versus Placebo [ Time Frame: From baseline to EOT, , aproximately 12 weeks ]
    See above

  3. 3. Percentage of patients that achieve a 50% reduction in wound surface area by week 4 [ Time Frame: Week 4 ]

Secondary Outcome Measures :
  1. 1. Change in mean CRP/ESR/PCT/WCC value for TP-102 versus Placebo [ Time Frame: From baseline to EOT, , aproximately 12 weeks ]
  2. 2. Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WCC [ Time Frame: Baseline to EOT, , aproximately 12 weeks ]
  3. 3. Percentage eradication of TP-102 susceptible strains for TP-102 versus Placebo at EOT; [ Time Frame: EOT, , aproximately 12 weeks ]
  4. 4. Percentage of patients with target strain not-susceptible to TP-102 for TP-102 versus Placebo at EOT; [ Time Frame: EOT, , aproximately 12 weeks ]

Eligibility Criteria
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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:

  • Aged ≥18 years old;
  • Established diagnosis of Diabetes Mellitus (type I or II);
  • Glycosylated hemoglobin (HbA1c) value < 12.0%;
  • Designated foot infection meets the following criteria:
  • Present for at least 3 weeks;
  • Below-ankle, full-thickness, cutaneous ulcer;
  • Wound area (after debridement, if applicable) 1 to 20.0 cm2;
  • PEDIS infection grade 2 or 3;
  • PEDIS perfusion grade 1 or 2;
  • PEDIS depth grade 1 or 2 (grade 3 at the discretion of the investigator e.g. if they have received appropriate surgical treatment to remove infected bones).
  • Diabetic foot infection with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii), susceptible to the TP-102 bacteriophage cocktail, as assessed from wound cultures;
  • Patients of suitable physical and mental health as determined by the Investigator on the basis of medical history and general physical examination;
  • Patients of childbearing potential must have a negative serum pregnancy test at screening;
  • ICF signed voluntarily before any study-related procedure is performed, indicating that the patient understands the purpose of, and procedures required in the study and is willing to participate in the study.

Exclusion Criteria:

  • Infected study ulcer less than 2 cm away from other ulcers, in the case of multiple ulcers;
  • Patient receiving hyperbaric oxygen therapy (HBOT), negative pressure wound therapy (NPWT), bioengineering skin (BES) substitutes and/or growth factors;
  • Patient which, in the opinion of the investigator, may not comply with study related procedures;
  • Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator's discretion);
  • Being pregnant or breastfeeding;
  • Currently participating in another clinical trial or having participated in a previous clinical trial with receipt of an investigational product within 30 days of the first administration of IP;
  • A condition that, in the opinion of the Investigator, could compromise the well-being of the patient or course of the study, or prevent the patient from meeting or performing any study requirements;
  • Participants with hypersensitivity to any component of investigational products.
Contacts and Locations
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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): NCT05948592


Contacts
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Contact: Sofia Corte Real +351215943993 scortereal@technophage.pt
Contact: Margarida Barreto mbarreto@technophage.pt

Locations
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United States, California
VA Greater LA Healthcare System Not yet recruiting
Los Angeles, California, United States, 90073
Contact: Aksone Nouvoung, DPM         
ILD Research Center Not yet recruiting
Vista, California, United States, 92081
Contact: Dean Vayser, MD         
United States, Florida
Keralty Hospital Miami Withdrawn
Miami, Florida, United States, 33155
India
MV Hospital for Diabetes Pvt. Ltd Recruiting
Chennai, India, 600013
Contact: G Senthil         
GSVM Medical College Recruiting
Kanpur, India
Contact: Sanjay Kala         
Crescent Hospital & Heart Centre Recruiting
Nagpur, India, 440012
Contact: Mohammad Qureshi         
Shree Siddhi Vinayak Hospital Recruiting
Nashik, India, 422002
Contact: Sachin Arsule         
Jupiter Hospital & Research Center Recruiting
Vadodara, India, 390012
Contact: Vikas Matai         
Parikh Multispeciality Healthcare Pvt. Ltd Recruiting
Vadodara, India, 390020
Contact: Parikh Niranjan         
Aman Hospital & Research Centre Recruiting
Vadodara, India, 390021
Contact: Aman Khanna         
Yalamanchi Hospitals & Research Centers Pvt. Ltd Recruiting
Vijayawada, India, 520002
Contact: Yalamanchi Rao         
Sponsors and Collaborators
Technophage, SA
VectorB2B
Investigators
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Principal Investigator: Jose David Suarez Keralty Hospital, Miami
Principal Investigator: Aksone Nouvong VA Greater Los Angeles Health Care
Principal Investigator: Sachin Arsule Shree Siddhi Vinayal Hospital
Principal Investigator: Yalamanchi Rao Yalamanchi Hospitals & Research Centers Pvt. Ltd
Principal Investigator: Senthil Kumar MV Hospital for Diabetes Pvt. Ltd
Principal Investigator: Aman Khanna Aman Hospital & Research Centre
Principal Investigator: Mohammad Qureshi Crescent Hospital & Heart Centre
Principal Investigator: Parikh Niranjan Parikh Multispeciality Healthcare Pvt. Ltd
Principal Investigator: Sanjay Kala GSVM Medical College
Principal Investigator: Vikas Matai Jupiter Hospital & Research Centre
More Information
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Responsible Party: Technophage, SA
ClinicalTrials.gov Identifier: NCT05948592    
Other Study ID Numbers: TP-102_102
First Posted: July 17, 2023    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
 Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies