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F510/08

A groundbreaking clinical trial is underway to assess the safety and effectiveness of TP-102, a new topical bacteriophage therapy for treating diabetic foot infections. This Phase 2b study aims to explore how TP-102, when used alongside standard care, compares to a placebo in managing infected diabetic foot ulcers caused by specific bacteria. The trial focuses on patients with diabetic foot infections and seeks to determine if this innovative approach can improve infection classification, wound healing, and overall patient outcomes.

Table of Contents

What is TP-102?

TP-102 is a new experimental medication being developed to treat diabetic foot infections. It is a bacteriophage therapy, which means it uses special viruses (bacteriophages) that can kill harmful bacteria without harming human cells.[1] TP-102 is a cocktail or mixture of five different bacteriophages: F44/10, F125/10, F770/05, F510/08, and F1245/05. Each of these bacteriophages targets specific types of bacteria that commonly cause foot infections in people with diabetes.

How does TP-102 work?

TP-102 is applied directly to the infected wound as a liquid suspension. The bacteriophages in TP-102 are designed to attack and kill specific bacteria that are causing the infection. This targeted approach is different from traditional antibiotics, which often kill both harmful and beneficial bacteria in the body.[1]

What conditions does TP-102 treat?

TP-102 is being developed to treat diabetic foot ulcers that are infected by specific types of bacteria. These bacteria include:

  • Acinetobacter baumannii: A type of bacteria that can cause serious infections, especially in healthcare settings.
  • Pseudomonas aeruginosa: A common bacteria that can cause infections in various parts of the body, including wounds.
  • Staphylococcus aureus: Often called “staph,” this bacteria is a frequent cause of skin and wound infections.

Diabetic foot ulcers are open sores or wounds that occur in about 15% of people with diabetes. These ulcers can become infected, leading to serious complications if not treated properly.[1]

Clinical Trial Details

TP-102 is currently being studied in a Phase 2b clinical trial. This means that the medication has already been tested for basic safety in humans, and now researchers are looking at how well it works and gathering more safety information.[1]

The trial is comparing TP-102 to a placebo (a treatment with no active ingredients), both given in addition to standard care for diabetic foot infections. This helps researchers determine if TP-102 provides additional benefits beyond current treatments.

Who can participate in the trial?

The trial is looking for participants who meet specific criteria, including:

  • Adults aged 18 or older
  • Diagnosed with diabetes (Type 1 or Type 2)
  • Have a diabetic foot infection that has been present for at least 3 weeks
  • The infection is caused by one of the bacteria that TP-102 targets
  • The foot ulcer meets specific size and severity criteria

There are also several conditions that would prevent someone from participating in the trial, such as pregnancy, certain other medical conditions, or use of specific treatments for the foot ulcer.[1]

What are the expected outcomes?

The researchers are looking at several outcomes to determine if TP-102 is effective and safe. These include:

  • Improvement in the severity of the foot infection
  • Reduction in the size of the wound
  • Complete healing of the wound
  • Elimination of the bacteria causing the infection
  • Changes in blood tests that indicate infection

The study will compare these outcomes between patients receiving TP-102 and those receiving the placebo.[1]

Safety Considerations

As with any new medication, safety is a primary concern. The researchers will be closely monitoring for any side effects or adverse reactions to TP-102. They will record any new medical problems that occur during the treatment period, known as Treatment Emergent Adverse Events (TEAEs).

It’s important to note that while bacteriophage therapy is a promising approach, TP-102 is still an experimental treatment. More research is needed to fully understand its effectiveness and safety profile.[1]

Aspect Details
Study Type Phase 2b clinical trial
Intervention TP-102 (bacteriophage cocktail) topical application
Target Condition Diabetic foot infections caused by specific bacteria
Primary Objectives Safety, tolerability, infection classification improvement, wound healing
Key Inclusion Criteria Adults with diabetes, specific foot ulcer characteristics, presence of target bacteria
Treatment Duration Up to 31 days
Main Outcomes Adverse events, changes in infection classification, wound size reduction, bacterial eradication

FAQ

  • What is TP-102 and how does it work? TP-102 is a topical bacteriophage therapy consisting of a cocktail of five bacteriophages (F44/10, F125/10, F770/05, F510/08, F1245/05). Bacteriophages are viruses that specifically target and destroy bacteria. In this case, TP-102 is designed to combat infections caused by Acinetobacter baumannii, Pseudomonas aeruginosa, and/or Staphylococcus aureus in diabetic foot ulcers.
  • Who is eligible to participate in this clinical trial? Eligible participants must be at least 18 years old, have a diagnosis of Diabetes Mellitus (type I or II), and have a diabetic foot infection that meets specific criteria. This includes having a below-ankle, full-thickness cutaneous ulcer present for at least 3 weeks, with a wound area up to 20 cm². The infection must be classified as mild to moderate and caused by bacteria susceptible to the TP-102 bacteriophage cocktail.
  • What are the main objectives of this clinical trial? The main objectives of this trial are to evaluate the safety and tolerability of TP-102 compared to a placebo, assess its efficacy in improving diabetic foot infection classification, and determine its effects on wound healing. The study will also look at changes in infection-related laboratory markers and the eradication of targeted bacterial strains.
  • How long does the treatment last in this trial? The maximum treatment period in this trial is 31 days. However, the study will continue to monitor participants beyond the treatment period to assess long-term outcomes, including wound healing and closure.
  • What are some of the expected outcomes of this trial? The trial aims to measure several outcomes, including the number and percentage of treatment-related adverse events, changes in infection classification, reduction in wound surface area, changes in wound size and depth, and the percentage of patients achieving complete wound closure. It will also assess the eradication of targeted bacterial strains and monitor for the development of bacterial resistance to TP-102.

Ongoing Clinical Trials on F510/08

  • Study on the Safety and Effectiveness of TP-102 for Treating Diabetic Foot Infections in Patients

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

Glossary

  • Bacteriophage: A virus that specifically infects and destroys bacteria. In this trial, bacteriophages are being used as a therapeutic agent to target specific bacterial infections in diabetic foot ulcers.
  • Diabetic Foot Infection (DFI): An infection that occurs in a foot wound of a person with diabetes. These infections can be serious and may lead to complications if not treated properly.
  • IWGDF/IDSA classification: A system used to categorize the severity of diabetic foot infections, developed by the International Working Group on the Diabetic Foot (IWGDF) and the Infectious Diseases Society of America (IDSA).
  • Standard of Care (SoC): The typical treatment or care given to patients with a specific condition. In this trial, TP-102 is being tested in addition to the standard of care for diabetic foot infections.
  • Topical administration: Application of a medication directly to the skin or wound surface, as opposed to taking it orally or through injection.
  • Phase 2b clinical study: A stage of clinical research that aims to determine the effectiveness and optimal dosage of a new treatment. It typically involves a larger group of patients than earlier phases.
  • Placebo: A substance with no active therapeutic effect, used as a control in clinical trials to test the effectiveness of a new treatment.
  • PEDIS classification: A system used to assess diabetic foot ulcers based on five categories: Perfusion, Extent, Depth, Infection, and Sensation.
  • Wound debridement: The removal of damaged tissue or foreign objects from a wound to improve the healing process.
  • Biomarkers: Measurable indicators in the body that can be used to assess the presence or severity of a disease, such as C-reactive protein (CRP) or white blood cell (WBC) count for infections.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-tp-102-for-treating-diabetic-foot-infections-in-patients/