Clinical trial NCT05948592: Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection
Official title: A Phase 2 CT to Evaluate the Safety and Efficacy of Topical Administration of Bacteriophage Therapy TP-102 in Patients With DFI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diabetic Foot Infection
Lead sponsor: Technophage, SA
Sponsor class: INDUSTRY
Collaborators: name: VectorB2B
First posted: 2023-07-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)).

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.

Eligibility 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.

Primary outcomes:
measure: 1. Number and percentage of treatment emergent adverse events (TEAEs)
timeFrame: From baseline to EOT, aproximately 12 weeks
measure: 2. Mean DFUWI score (total AUC) for TP-102 versus Placebo
timeFrame: From baseline to EOT, , aproximately 12 weeks
measure: 3. Percentage of patients that achieve a 50% reduction in wound surface area by week 4
timeFrame: Week 4
Secondary outcomes:
measure: 1. Change in mean CRP/ESR/PCT/WCC value for TP-102 versus Placebo
timeFrame: From baseline to EOT, , aproximately 12 weeks
measure: 2. Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WCC
timeFrame: Baseline to EOT, , aproximately 12 weeks
measure: 3. Percentage eradication of TP-102 susceptible strains for TP-102 versus Placebo at EOT;
timeFrame: EOT, , aproximately 12 weeks
measure: 4. Percentage of patients with target strain not-susceptible to TP-102 for TP-102 versus Placebo at EOT;
timeFrame: EOT, , aproximately 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Clemente Clinical Research
state: California
city: Webster
country: United States
facility: Tranquil Clinical Research
state: Texas
city: Chennai
country: India
facility: MV Hospital for Diabetes Pvt. Ltd
city: Kanpur
country: India
facility: GSVM Medical College
city: Nagpur
country: India
facility: Crescent Hospital & Heart Centre
city: Nashik
country: India
facility: Shree Siddhi Vinayak Hospital
city: Vadodara
country: India
facility: Jupiter Hospital & Research Center
city: Vadodara
country: India
facility: Parikh Multispeciality Healthcare Pvt. Ltd
city: Vadodara
country: India
facility: Aman Hospital & Research Centre
city: Vijayawada
country: India
facility: Yalamanchi Hospitals & Research Centers Pvt. Ltd
Study officials:
affiliation: Shree Siddhi Vinayal Hospital
name: Sachin Arsule
role: PRINCIPAL_INVESTIGATOR
affiliation: Yalamanchi Hospitals & Research Centers Pvt. Ltd
name: Yalamanchi Rao
role: PRINCIPAL_INVESTIGATOR
affiliation: MV Hospital for Diabetes Pvt. Ltd
name: Senthil Kumar
role: PRINCIPAL_INVESTIGATOR
affiliation: Aman Hospital & Research Centre
name: Aman Khanna
role: PRINCIPAL_INVESTIGATOR
affiliation: Crescent Hospital & Heart Centre
name: Mohammad Qureshi
role: PRINCIPAL_INVESTIGATOR
affiliation: Parikh Multispeciality Healthcare Pvt. Ltd
name: Parikh Niranjan
role: PRINCIPAL_INVESTIGATOR
affiliation: GSVM Medical College
name: Sanjay Kala
role: PRINCIPAL_INVESTIGATOR
affiliation: Jupiter Hospital & Research Centre
name: Vikas Matai
role: PRINCIPAL_INVESTIGATOR
affiliation: Clemente Clinical Research
name: Stan Mathis, PI
role: PRINCIPAL_INVESTIGATOR
affiliation: Tranquil Clinical Research
name: Abdul Moosa, PI
role: PRINCIPAL_INVESTIGATOR
References: