Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection

Last updated: August 2, 2024
Sponsor: Technophage, SA
Overall Status: Active - Recruiting

Phase

2

Condition

Diabetes Mellitus Types I And Ii

Diabetes And Hypertension

Treatment

Placebo

TP-102

Clinical Study ID

NCT05948592
TP-102_102
  • Ages > 18
  • All Genders

Study 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)).

Eligibility Criteria

Inclusion

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 theyhave received appropriate surgical treatment to remove infected bones).

  • Diabetic foot infection with at least one target bacterial strain (Pseudomonasaeruginosa, Staphylococcus aureus or Acinetobacter baumannii), susceptible to theTP-102 bacteriophage cocktail, as assessed from wound cultures;

  • Patients of suitable physical and mental health as determined by the Investigator onthe basis of medical history and general physical examination;

  • Patients of childbearing potential must have a negative serum pregnancy test atscreening;

  • ICF signed voluntarily before any study-related procedure is performed, indicatingthat the patient understands the purpose of, and procedures required in the studyand is willing to participate in the study.

Exclusion

Exclusion Criteria:

  • Infected study ulcer less than 2 cm away from other ulcers, in the case of multipleulcers;

  • 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 relatedprocedures;

  • Presence of active malignant or benign tumors of any kind, (with exception tononmelanoma skin cancer as per investigator's discretion);

  • Being pregnant or breastfeeding;

  • Currently participating in another clinical trial or having participated in aprevious clinical trial with receipt of an investigational product within 30 days ofthe first administration of IP;

  • A condition that, in the opinion of the Investigator, could compromise thewell-being of the patient or course of the study, or prevent the patient frommeeting or performing any study requirements;

  • Participants with hypersensitivity to any component of investigational products.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 08, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • MV Hospital for Diabetes Pvt. Ltd

    Chennai, 600013
    India

    Active - Recruiting

  • GSVM Medical College

    Kanpur,
    India

    Active - Recruiting

  • Crescent Hospital & Heart Centre

    Nagpur, 440012
    India

    Active - Recruiting

  • Shree Siddhi Vinayak Hospital

    Nashik, 422002
    India

    Active - Recruiting

  • Aman Hospital & Research Centre

    Vadodara, 390021
    India

    Active - Recruiting

  • Jupiter Hospital & Research Center

    Vadodara, 390012
    India

    Active - Recruiting

  • Parikh Multispeciality Healthcare Pvt. Ltd

    Vadodara, 390020
    India

    Active - Recruiting

  • Yalamanchi Hospitals & Research Centers Pvt. Ltd

    Vijayawada, 520002
    India

    Active - Recruiting

  • Clemente Clinical Research

    Los Angeles, California 90033
    United States

    Site Not Available

  • VA Greater LA Healthcare System

    Los Angeles, California 90073
    United States

    Site Not Available

  • ILD Research Center

    Vista, California 92081
    United States

    Active - Recruiting

  • Keralty Hospital Miami

    Miami, Florida 33155
    United States

    Site Not Available

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