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Demerecviridae Bacteriophage Against Klebesiella Pneumoniae (113.073 Bp)

A new clinical trial is underway to assess the safety and effectiveness of a bacteriophage cocktail called TP-122A in treating ventilator-associated pneumonia (VAP). This Phase 1/2a study aims to evaluate how well patients tolerate multiple doses of TP-122A when administered alongside standard care. The trial focuses on adult patients with VAP caused by specific bacteria and will measure various outcomes, including adverse events, clinical response, and time spent on mechanical ventilation.

Table of Contents

What is DEMERECVIRIDAE BACTERIOPHAGE?

DEMERECVIRIDAE BACTERIOPHAGE AGAINST KLEBESIELLA PNEUMONIAE (113.073 BP) is a type of virus that specifically targets and kills the bacteria Klebsiella pneumoniae. It is part of a new medication called TP-122, which is a bacteriophage cocktail. This means it contains several different types of viruses, each designed to fight specific harmful bacteria.[1]

The full name of this treatment is quite complex, so let’s break it down:

  • DEMERECVIRIDAE: This is the family of viruses to which this bacteriophage belongs.
  • BACTERIOPHAGE: This term means a virus that infects and kills bacteria.
  • AGAINST KLEBESIELLA PNEUMONIAE: This indicates that the virus specifically targets the bacteria Klebsiella pneumoniae.
  • (113.073 BP): This likely refers to the size of the virus’s genetic material, measured in base pairs (BP).

How Does It Work?

Bacteriophages work by infecting specific bacteria and using the bacteria’s own machinery to replicate themselves. In the process, they destroy the bacteria. This is different from traditional antibiotics, which often kill a wide range of bacteria, including beneficial ones.[1]

TP-122, which includes the DEMERECVIRIDAE BACTERIOPHAGE, is designed to target two types of bacteria that commonly cause pneumonia in patients on ventilators: Klebsiella pneumoniae and Pseudomonas aeruginosa. The cocktail contains six different bacteriophages, each targeting specific strains of these bacteria.[1]

What Does It Treat?

The primary focus of the current clinical trial is to test TP-122 (which includes DEMERECVIRIDAE BACTERIOPHAGE) for the treatment of Ventilator-Associated Pneumonia (VAP). VAP is a serious lung infection that can occur in people who are on mechanical ventilation. It’s a significant concern in intensive care units and can be life-threatening.[1]

Current Clinical Trial

A clinical trial is currently underway to assess the safety and effectiveness of TP-122. This is a Phase 1/2a trial, which means it’s one of the earliest stages of testing in humans. The main goals of this trial are:[1]

  1. To evaluate the safety and tolerability of TP-122 when given through nebulization (a method of turning liquid medicine into a fine mist that can be inhaled) every 8 hours for 7 days.
  2. To determine how well patients respond to TP-122 when it’s given alongside standard care, compared to patients who receive only standard care.
  3. To measure how TP-122 affects the number of days patients spend on mechanical ventilation and in the intensive care unit.

How Is It Administered?

In the current trial, TP-122 is being administered through nebulization. This means the medication is turned into a fine mist that patients can inhale directly into their lungs. For patients on ventilators, this mist can be delivered through the breathing tube. The treatment is given every 8 hours for 7 days.[1]

Who Is Eligible for Treatment?

The clinical trial has specific criteria for who can participate. Some key points include:[1]

  • Patients must be 18 years or older
  • They must have Ventilator-Associated Pneumonia
  • They must have a confirmed infection with Pseudomonas aeruginosa in their lower respiratory tract
  • Patients with certain conditions are excluded, such as those with severe asthma, certain types of cancer, or who are immunocompromised

It’s important to note that these criteria are specific to this clinical trial and may not reflect who might be eligible for the treatment if it’s approved for general use in the future.

Safety and Side Effects

One of the main goals of the current clinical trial is to assess the safety of TP-122. The researchers will be closely monitoring for any adverse events (side effects) that occur during the trial. They will be looking at:[1]

  • The number and severity of side effects
  • Changes in laboratory test results
  • Changes in vital signs
  • Changes in electrocardiogram (ECG) results

As this is an early-stage trial, the full range of potential side effects is not yet known. This is why careful monitoring is a crucial part of the study.

Future Prospects

If TP-122 (including DEMERECVIRIDAE BACTERIOPHAGE) proves to be safe and effective in this and future clinical trials, it could become an important new treatment for Ventilator-Associated Pneumonia. This could be particularly valuable given the growing problem of antibiotic resistance, where traditional antibiotics are becoming less effective against certain bacteria.[1]

However, it’s important to remember that this treatment is still in the early stages of testing. More research is needed to fully understand its effectiveness and safety before it can be considered for widespread use.

Aspect Details
Study Type Randomized, Parallel, Open-Label, Phase 1/2a
Condition Ventilator-Associated Pneumonia (VAP)
Intervention TP-122A (bacteriophage cocktail) + Standard of Care
Administration Nebulization every 8 hours for 7 days
Primary Objective Evaluate safety and tolerability of TP-122A
Secondary Objectives Assess clinical response, microbiological response, duration of mechanical ventilation, ICU stay
Key Inclusion Criteria Adults with VAP, P. aeruginosa infection, stable ventilatory requirements
Key Exclusion Criteria Severe asthma, immunocompromised status, recent cancer treatment, pregnancy
Primary Endpoints Adverse events, changes in clinical laboratory parameters, vital signs, ECG
Secondary Endpoints Clinical cure rate, time to clinical cure, microbiological response, mechanical ventilation days, ICU stay duration, survival rate

FAQ

  • What is TP-122A and how does it work? TP-122A is a bacteriophage cocktail, which means it contains viruses that specifically target and kill certain bacteria. In this case, it's designed to combat Pseudomonas aeruginosa and Klebsiella pneumoniae, two bacteria that can cause ventilator-associated pneumonia.
  • Who is eligible for this clinical trial? The trial is open to adults (18 years or older) with ventilator-associated pneumonia who meet specific criteria, including having a microbiological diagnosis of P. aeruginosa infection in the lower respiratory tract. Patients must also have stable ventilatory requirements and be able to provide informed consent.
  • How is TP-122A administered in this trial? TP-122A is administered through nebulization, which means it's turned into a fine mist that patients can inhale. In this study, patients receive multiple doses every 8 hours for 7 days, in addition to standard care treatment.
  • What are the main goals of this clinical trial? The primary goal is to evaluate the safety and tolerability of TP-122A. Secondary goals include assessing how well it works in treating the infection, how quickly it works, and its impact on the duration of mechanical ventilation and ICU stay.
  • Are there any specific exclusion criteria for this trial? Yes, there are several exclusion criteria. These include having certain medical conditions like severe asthma, being immunocompromised, having a history of cancer requiring chemotherapy or radiation in the past 5 years, and being pregnant or breastfeeding, among others.

Ongoing Clinical Trials on Demerecviridae Bacteriophage Against Klebesiella Pneumoniae (113.073 Bp)

  • Safety and tolerability study of bacteriophage cocktail TP-122A given by inhalation in adults with ventilator-associated pneumonia

    Not yet recruiting

    1 1
    Investigated drugs:
    The Netherlands Portugal

  • Study on the Safety and Tolerability of TP-122 for Treating Ventilator-Associated Pneumonia in Adults

    Not yet recruiting

    1 1
    Investigated drugs:
    France

Glossary

  • Ventilator-Associated Pneumonia (VAP): A type of lung infection that occurs in people who are on mechanical ventilation breathing machines in hospitals.
  • Bacteriophage: A virus that infects and replicates within bacteria. In this context, it's used as a treatment to target specific harmful bacteria.
  • Nebulization: The process of converting a liquid into a fine spray or mist, often used to administer medications directly to the lungs.
  • Standard of Care (SoC): The typical treatment or care given to patients with a specific condition, based on current medical knowledge and practices.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.
  • Serious Adverse Event (SAE): An adverse event that results in death, is life-threatening, requires hospitalization, causes a significant incapacity, or requires intervention to prevent permanent impairment.
  • Clinical Response (CR): The measurable improvement in a patient's condition in response to treatment.
  • Microbiological Response (MR): The effect of treatment on the presence and amount of bacteria causing the infection.
  • Mechanical Ventilation (MV): The use of a machine to help a patient breathe when they are unable to breathe sufficiently on their own.
  • Intensive Care Unit (ICU): A special department in a hospital that provides intensive care medicine to critically ill patients.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-tolerability-of-tp-122-for-treating-ventilator-associated-pneumonia-in-adults/