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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as ventilator-associated pneumonia, which is a type of lung infection that can occur in people who are on mechanical ventilators in hospitals. The treatment being tested is called TP-122A, a special mixture of bacteriophages. Bacteriophages are tiny viruses that specifically target and destroy bacteria. In this study, TP-122A is designed to fight against two types of bacteria: Klebsiella pneumoniae and Pseudomonas aeruginosa, which are often responsible for causing ventilator-associated pneumonia.

The purpose of the study is to evaluate the safety and tolerability of TP-122A when given to patients with ventilator-associated pneumonia. Participants in the study will receive multiple doses of TP-122A through inhalation every 8 hours for 7 days. The study will compare the effects of TP-122A combined with standard care to standard care alone. Throughout the study, researchers will monitor participants for any side effects and changes in their health, including vital signs and laboratory tests.

The study aims to understand how well TP-122A is tolerated by patients and whether it can help improve their condition. Researchers will also look at how quickly patients recover from the infection and how long they need to stay on a ventilator or in the intensive care unit. The ultimate goal is to find out if TP-122A can be a safe and effective treatment option for people with ventilator-associated pneumonia.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, consent is required. If unable to provide consent personally, a family member or trusted person may do so.
Eligibility includes being 18 years or older and having ventilator-associated pneumonia (VAP) with stable ventilatory requirements.
Step 2
Treatment initiation
The treatment involves the administration of a bacteriophage cocktail called TP-122A.
The medication is given through inhalation as a suspension.
Step 3
Medication schedule
The TP-122A is administered every 8 hours for a duration of 7 days.
This is in addition to the standard care (SoC) provided for VAP.
Step 4
Monitoring and assessments
Throughout the trial, various assessments are conducted to monitor safety and tolerability.
These include checking for adverse events, changes in clinical laboratory parameters, vital signs, and electrocardiogram (ECG) results.
Step 5
Follow-up
After the treatment period, follow-up assessments are conducted to evaluate the outcomes.
These assessments include checking for clinical cure, microbiological response, and overall survival.

Who can join the trial?

8 criteria

Subjects must be able and willing to sign the informed consent form. If the subject cannot do so, a family member or trusted person can provide consent.
Subjects must be 18 years old or older.
Subjects must have **Ventilator-Associated Pneumonia (VAP)** with stable breathing support needs. This includes specific measures of oxygen levels and breathing support settings.
Subjects must show at least one of the following: low oxygen levels, need for changes in breathing support to improve oxygen, or new respiratory secretions.
Subjects must show at least one of the following signs: fever, low body temperature, high or low white blood cell count, or a high percentage of immature white blood cells.
Subjects must have a confirmed infection with **P. aeruginosa** in the lower respiratory tract, diagnosed through specific tests.
Female subjects who can have children must have a negative pregnancy test at the start of the study.
Subjects must be registered in a social security scheme.

Who cannot join the trial?

6 criteria

Patients who are not adults cannot participate. This means only individuals who are 18 years or older are eligible.
Patients who are part of a vulnerable population are not allowed to join. A vulnerable population includes groups like pregnant women, prisoners, or those unable to give consent.
Patients who have medical conditions other than **Ventilator-Associated Pneumonia** may not be eligible. **Ventilator-Associated Pneumonia** is a lung infection that occurs in people who are on a ventilator, a machine that helps them breathe.
Patients who cannot follow the study procedures, such as taking the medication every 8 hours for 7 days, may be excluded.
Patients who have allergies or reactions to the study medication or its ingredients may not be able to participate.
Patients who are currently participating in another clinical trial may not be eligible.

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Verified sites

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Centre Hospitalier Et Universitaire De Limoges
Limoges, France
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Centre Hospitalier Universitaire De Nantes
Nantes, France

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Investigated drugs

TP-122A
is a bacteriophage cocktail being studied for its potential to treat ventilator-associated pneumonia. Bacteriophages are viruses that specifically target and destroy bacteria. In this trial, TP-122A is administered through nebulization, which means it is inhaled as a mist, allowing it to reach the lungs directly. The study aims to assess the safety and tolerability of this treatment when given multiple times a day over a week.
Standard of Care (SoC)
refers to the usual treatment provided to patients with ventilator-associated pneumonia. This can include antibiotics and other supportive measures to help manage the infection and support the patient's breathing. In this trial, TP-122A is given in addition to the standard of care to see if it offers any additional benefits.

What is already known about the treatment

TP-122A – This medication is administered through nebulization, which involves inhaling the medication in the form of a mist. It is currently being studied in clinical trials, specifically in a Phase 1/2a study, to evaluate its safety and tolerability for treating Ventilator-Associated Pneumonia (VAP). The main therapeutic indication for TP-122A is the treatment of VAP, a serious lung infection that occurs in people using mechanical ventilation. At the molecular level, TP-122A is a bacteriophage cocktail, which means it uses viruses that specifically target and destroy bacteria causing the infection. It falls under the pharmacological classification of bacteriophage therapy, an innovative approach to combat bacterial infections.

Investigated diseases

Ventilator-Associated Pneumonia – This is a type of lung infection that occurs in people who are on mechanical ventilation breathing machines in hospitals. It typically develops 48 hours or more after mechanical ventilation is initiated. The disease is caused by bacteria that enter the lungs through the ventilator tube. Symptoms may include fever, increased white blood cell count, and purulent sputum. The progression of the disease can lead to worsening respiratory function and increased oxygen requirements. It is a common complication in intensive care units and requires careful monitoring.