A Phase 3, Multi-Center, Randomized, Single-Blind Study to Assess the Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy in Adults With Complicated Urinary Tract Infection, Acute Uncomplicated Pyelonephritis, Hospital-Acquired Bacterial Pneumonia, Ventilator-Associated Bacterial Pneumonia, and Complicated Intra-Abdominal Infection due to Carbapenem Resistant Enterobacterales (OP0595-6)
This research study is testing new combinations of medicines (like Cefepime/Nacubactam and Aztreonam/Nacubactam) for serious bacterial infections. These infections include complicated urinary tract infections, severe kidney infections, pneumonia caught in hospitals (including those needing a ventilator), and complicated tummy infections. The main goal is to find out if these new treatments are effective and safe for adults, especially when infections are resistant to other powerful antibiotics called carbapenems. Researchers will compare these new medicines to the best available standard treatments. By taking part, you could help doctors find better ways to treat these difficult infections in the future.
At a glance
What is this study about?
Imagine you have a serious infection, like a really bad water infection that's spread, or a chest infection you caught in hospital. Sometimes, these infections are caused by bacteria that have become very clever and can resist many of the standard antibiotics doctors usually use. This can make them very difficult to treat, and it's a growing problem in hospitals.
This study is looking for new ways to fight these 'superbugs'. Researchers are testing two new combinations of medicines (named Cefepime/Nacubactam and Aztreonam/Nacubactam) against these resistant bacteria. They want to see if these new treatments work better and are safer than what doctors currently offer. The infections being studied include complicated urine infections, severe kidney infections, serious chest infections (like pneumonia, including those caught while on a breathing machine), and complicated tummy infections.
The study is a 'Phase 3' trial, which means these new medicines have already shown promise in earlier tests. Now, they need to be tested in a larger group of patients to confirm how well they work and check for any side effects, comparing them to standard treatments. The main aim is to see if more patients get better with the new medicines compared to the current best available care. Taking part could help doctors understand how to better treat serious antibiotic-resistant infections in the future, which is very important for patient care.
Key takeaways
- Tests new antibiotic combinations for serious infections.
- Aims to find better treatments for antibiotic-resistant bacteria.
- Compares new medicines to current standard care.
- Focuses on complicated urine, kidney, pneumonia, and tummy infections.
- Phase 3 trial, meaning medicines have shown promise in earlier tests.
- Contributes to future understanding of infection treatment.
Who may be eligible?
To be considered for this study, you would need to be an adult, aged 18 years or older. Both men and women are welcome to take part. The study is specifically looking for people who have one of the particular serious bacterial infections being investigated, such as a complicated urinary tract infection, a severe kidney infection, or certain types of pneumonia or abdominal infections.
There might be other health conditions or medications that would mean you couldn't join, as these studies need to ensure participant safety and reliable results. For example, if you have certain kidney or liver problems, or are on specific treatments, you might not be eligible. Not everyone with these infections will be suitable for the study, and a doctor will carefully review your medical history.
Your doctor will discuss all the detailed requirements with you to see if this study could be an option. They will make sure it's safe for you to participate and that your involvement would be helpful for the research.
- Are you 18 years old or older?
- Do you have a complicated urinary tract infection, severe kidney infection, or certain hospital-acquired pneumonia or complicated tummy infection?
- Are you able to attend regular follow-up appointments?
- Are you able to understand and agree to the study requirements?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would be given one of the study medications for your serious infection. This would involve receiving the medicine, likely through an injection or an drip (infusion) into a vein, similar to how antibiotics are often given in hospital. You would be compared to other patients who receive the best available standard treatment for their infection.
You would have regular check-ups with the study doctors and nurses. These visits would involve looking at how you are feeling, taking blood or urine samples, and checking your infection to see if the treatment is working. They would also monitor you closely for any side effects. The study team would explain the full schedule of visits, assessments, and the expected duration of treatment and follow-up, which would depend on the type of infection you have. The exact number of hospital visits or assessments would be clearly outlined before you agree to participate.
Potential risks and benefits
Locations (7)
- —France
- —Czechia
- —Greece
- —Slovakia
- —Latvia
- —Croatia
- —Spain
Common questions
What kind of infections is this study looking at?
The study focuses on serious bacterial infections like complicated urine infections, severe kidney infections, particular types of pneumonia, and complex tummy infections.
Why are new medicines needed for these infections?
Some bacteria are becoming 'superbugs' and can resist common antibiotics, making infections very difficult to treat. This study hopes to find more effective new treatments.
How will I know if the new medicine works?
Doctors will regularly check your infection through tests and monitor your symptoms to see if your condition improves with the treatment.
Will I definitely get one of the new medicines?
Not necessarily. In this study, some participants will receive one of the new medicines, while others will receive the best standard care available, so doctors can compare them.
Are there any costs for taking part?
No, you will not have to pay for any study-related medicines or appointments.
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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