A Phase 3, Multi-Center, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Cefepime/Nacubactam or Aztreonam/Nacubactam Compared to Imipenem/Cilastatin in the Treatment of Complicated Urinary Tract Infections or Acute Uncomplicated Pyelonephritis, in Adults (OP0595-5)
This study, called "OP0595-5," is a major research project looking into new treatments for adults with serious urine infections. This includes complicated urinary tract infections (cUTI) or acute kidney infections (pyelonephritis). Researchers want to find out if two new medicines, which include "Nacubactam," are as good as or better than a commonly used medicine called imipenem/cilastatin. They are especially interested in whether these new medicines can cure the infection and make people feel better. The study also checks for any side effects of the new drugs. It's a key step to see if these new medicines could be used more widely in the future.
At a glance
What is this study about?
Imagine you have a serious urine infection, or an infection that has spread to your kidneys. These can be quite nasty and sometimes tough to treat with usual antibiotics. This particular study is a big step in finding new and better ways to tackle these infections.
Researchers are testing some new medicines to see if they are safe and effective. These new medicines involve a component called "Nacubactam," and they are being compared to a medicine that doctors already use often for these types of infections. The main goal is to figure out if these new medicines can completely clear the infection from your body and help you feel much better.
This kind of study, called a "Phase 3" study, is usually the last step before a medicine might be approved for wider use. It means that the medicines have already shown some promise in earlier tests. By comparing them to an existing treatment, researchers can be sure they are making a real difference for patients.
Key takeaways
- This study tests new medicines for serious urine and kidney infections.
- It compares new treatments with one already commonly used.
- The main goal is to see if new medicines are safe and can fully clear infections.
- It's a Phase 3 study, a key step before potential wider use.
- Adults (18+) with specific types of infections may be eligible.
- Your health will be closely monitored throughout the study.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women are welcome to take part. Researchers are specifically looking for adults who have either a 'complicated urinary tract infection' or an 'acute uncomplicated pyelonephritis'.
A complicated urinary tract infection means a urine infection that might be harder to treat, perhaps because of other health problems you have or issues with your urinary system. Acute uncomplicated pyelonephritis is a sudden kidney infection that isn't made more complex by other underlying conditions.
There will be other specific health requirements that your doctor will check to make sure the study is a safe and suitable option for you.
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 complicated urinary tract infection?
- Or do you have an acute kidney infection (pyelonephritis)?
- Are you able to attend all required study appointments?
- Are you willing to receive one of the study medicines, potentially a new one, via IV?
- Are you comfortable with regular health checks and sample collections?
What does participation involve?
If you decide to join this study, you would receive one of the study medicines through an IV drip. You wouldn't know if you're getting the new medicine or the standard one. You will have regular appointments where doctors will monitor your health, take samples (like urine and blood) to check the infection, and see how you are feeling.
These checks will happen at various points: while you're receiving the treatment, soon after, and then at follow-up visits. A key check is called the "Test of Cure" visit, where doctors confirm if the infection is gone and you've recovered. There will also be longer-term follow-up visits to make sure the infection doesn't come back. The total duration of your participation, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (6)
- —UnverifiedLatvia
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- —UnverifiedBulgaria
- —UnverifiedEstonia
- —UnverifiedCzechia
- —UnverifiedLithuania
Common questions
What is a 'complicated urinary tract infection'?
It's a urine infection that might be harder to treat, often because of other health conditions or problems with your urinary system.
What is 'acute uncomplicated pyelonephritis'?
This is a sudden infection of the kidneys that isn't made more complex by other existing health problems.
Will I know which medicine I'm getting?
No, this is a 'blind' study, meaning neither you nor your study doctor will know if you're getting the new medicine or the standard one. This helps make the study results fair.
What does 'Test of Cure' mean?
This is a special check-up to see if the infection has been completely cleared from your body and if your symptoms have significantly improved.
Can I leave the study if I want to?
Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.
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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