A Randomized, Parallel, Open-Label, Phase 1/2a Study to Assess the Safety and Tolerability of Multiple Doses of the Bacteriophage Cocktail TP-122 (Component TP-122A), for the Treatment of Ventilator-Associated Pneumonia
This research study is looking into a new treatment for a severe lung infection known as ventilator-associated pneumonia. This infection often affects people who are on a breathing machine (ventilator) in the hospital's intensive care unit. The new treatment, called TP-122, is a special mixture designed to fight the bacteria causing these infections. The main goals of this study are to check if TP-122 is safe to use and how well patients tolerate it when given alongside the usual care. Researchers will also be looking to see if TP-122 helps patients recover from their infection, reduces their time on the breathing machine, and helps them leave intensive care sooner.
At a glance
What is this study about?
This study is investigating a new medication called TP-122, which is being developed to treat a serious lung infection known as ventilator-associated pneumonia (VAP). VAP can be very dangerous and often affects people who are already very unwell and need help breathing from a machine called a ventilator, typically in an intensive care unit (ICU).
The new treatment, TP-122, is designed to target and fight the specific types of bacteria that cause VAP. It's different from regular antibiotics and is made up of tiny viruses called bacteriophages, which naturally attack bacteria. This study aims to find out if TP-122 can be a helpful new tool to improve treatment for people with this challenging infection.
Researchers will be carefully checking how safe TP-122 is and how well patients' bodies handle it. They will also compare patients who receive TP-122 plus standard care to those who only receive standard care, to see if adding TP-122 leads to better recovery, quicker healing from the infection, less time needed on a ventilator, and earlier discharge from the ICU. Your participation could help us learn valuable information that could improve treatment for future patients.
Key takeaways
- Tests a new treatment (TP-122) for severe lung infection (ventilator-associated pneumonia).
- Aims to check safety and how well patients tolerate the new treatment.
- Compares TP-122 plus standard care to standard care alone.
- Hopes to improve patient recovery, reduce time on breathing machines, and shorten ICU stays.
- Involves close monitoring with blood tests, ECGs, and vital signs.
Who may be eligible?
To be part of this study, you would need to be an adult, aged 18 or older.
Gender or sex does not matter; both men and women are welcome to participate. The most important factor is that you have been diagnosed with ventilator-associated pneumonia and meet other specific medical criteria that the study doctors will check.
As this is a study for a serious condition, your medical team will carefully review your health records to make sure the study is a suitable option for you and that taking part would be safe.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of ventilator-associated pneumonia?
- Are you currently in intensive care, possibly on a breathing machine?
- Are you able to provide consent, or do you have a family member who could do so on your behalf?
- Have your doctors determined that joining the study would be safe for you?
What does participation involve?
If you join this study, you would receive the new study medication, TP-122, in addition to the usual care you would already be getting for your pneumonia. The study medication is given alongside standard treatments. You would have regular medical check-ups, which include blood tests, monitoring your heart (with an ECG), and keeping track of your vital signs like temperature and blood pressure. These checks are to make sure you are safe and to see how your body is responding to the treatment.
Doctors will also monitor your recovery from the infection, how long you need to be on a ventilator, and when you can leave the intensive care unit. There will be some follow-up appointments after you leave the ICU to ensure your continued health. The overall duration of your participation in the study would depend on your recovery, but the study team will explain all the timings to you in detail.
Potential risks and benefits
Locations (2)
- —UnverifiedPortugal
- —UnverifiedNetherlands
Common questions
What is ventilator-associated pneumonia?
It's a serious lung infection that can affect people who are on a breathing machine (ventilator) in the hospital, often in intensive care.
What is TP-122?
TP-122 is a new study medication that uses special viruses called bacteriophages to target and kill the bacteria causing the pneumonia.
Will I still get my usual treatment?
Yes, if you join this study, you will receive TP-122 in addition to the standard treatments you would normally receive for your pneumonia.
What types of checks will I have?
You'll have regular blood tests, heart checks (ECG), vital sign measurements, and close monitoring of your infection and overall recovery.
Can I stop being part of the study?
Yes, you can choose to leave the study at any time, and this will not affect the medical care you receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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