Bacteriophage Therapy TP-102 in Patients With Diabetic Foot Infection

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)).

Conditions

• Diabetic Foot Infection

Interventions

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).

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).

Sponsors & Collaborators

• VectorB2B

  collaborator INDUSTRY

• Technophage, SA

  lead INDUSTRY

Principal Investigators

• Abdul Moosa, PI · Tranquil Clinical Research

• Sachin Arsule · Shree Siddhi Vinayal Hospital

• Yalamanchi Rao · Yalamanchi Hospitals & Research Centers Pvt. Ltd

• Senthil Kumar · MV Hospital for Diabetes Pvt. Ltd

• Aman Khanna · Aman Hospital & Research Centre

• Mohammad Qureshi · Crescent Hospital & Heart Centre

• Parikh Niranjan · Parikh Multispeciality Healthcare Pvt. Ltd

• Sanjay Kala · GSVM Medical College

• Vikas Matai · Jupiter Hospital & Research Centre

• Stan Mathis, PI · Clemente Clinical Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-08

Primary Completion

2025-10-30

Completion

2025-12-19

FDA Drug

Yes

Countries

• United States
• India

Study Locations