Real-world Multicentre Study of AZtreonam-AVIbactam Treatment With Infections or Suspected Infections Caused by Multidrug-resistant Gram-negative Bacteria
This study, called AZAVI, is designed to understand how well a new antibiotic called Aztreonam-Avibactam (ATM-AVI) works for patients with serious infections caused by bacteria that are very hard to treat. These resistant bacteria often don't respond to many common antibiotics. The study is collecting information from hospitals across the UK, including intensive care units (ICU) and infectious disease departments. Researchers are looking at patient records from before the drug was widely available (a 'retrospective' look) and are also following new patients who are given the drug now (a 'prospective' look). They want to see if the antibiotic successfully clears the infection and helps patients recover, how safe it is, and if there are any side effects. The aim is to gather real-world evidence on this important new treatment.
At a glance
What is this study about?
Imagine feeling very unwell with an infection that regular antibiotics can't beat. This is becoming more common partly because some bacteria are getting smarter and resisting our medicines. This study is about a new antibiotic treatment called Aztreonam-Avibactam, often shortened to ATM-AVI, which is designed to fight these very stubborn infections.
This study, called AZAVI, is a bit like gathering detective clues from hospitals all over the UK. Doctors want to understand how ATM-AVI works for real patients, not just in strict lab tests. They are especially interested in serious infections that need treatment in hospital, often in an intensive care unit (ICU).
They're doing this by looking at two groups of patients: first, those who were treated with this antibiotic in the past year, and second, patients who are being treated with it now. By carefully tracking how these patients get on – like whether their infection clears up, if they have side effects, and how quickly they recover – the study hopes to give doctors a much clearer picture of how effective and safe this new treatment is in everyday hospital care. This information will help doctors make the best decisions for future patients with similar challenging infections.
Key takeaways
- The study looks at an important new antibiotic for very resistant infections.
- It collects 'real-world' information from patients already receiving the treatment.
- No extra treatments, tests, or hospital visits are involved for participants.
- The goal is to help doctors understand the drug's effectiveness and safety.
- Your privacy is protected, and you can opt out at any time.
- It helps guide future treatments for challenging infections.
Who may be eligible?
To be considered for this study, you would need to be a patient in hospital with an infection that your doctors suspect or have confirmed is caused by a type of bacteria that is very resistant to usual antibiotics. This means the infection is quite challenging to treat, and your doctor thinks Aztreonam-Avibactam is an appropriate treatment for you.
The main thing that would stop you from being included is if you, or someone legally responsible for you, clearly states that you do not want your information to be part of the study. Your choice is always respected.
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 currently in hospital?
- Do you have a serious infection suspected or confirmed to be very resistant to antibiotics?
- Are your doctors treating you with Aztreonam-Avibactam?
- Have you or your legal representative not refused to share your health information for research?
What does participation involve?
If you are already receiving the antibiotic Aztreonam-Avibactam because your doctors believe it's the best treatment for your specific infection, your information may be included in this study. You wouldn't need to do anything extra. This isn't a study where you try a new drug just for research; it's about observing how the drug works when doctors decide to use it in their usual care.
The research team would simply collect information from your existing medical records. This includes details about your infection, the treatment you received, how you responded, and any side effects. There are no extra visits, tests, or procedures required beyond what your medical team would do anyway for your normal care. Data will be collected over time to see how the infection progresses and how you recover.
Potential risks and benefits
Locations (1)
- French Society of Intensive Care (SRLF)Verified postcodeParis, France
Common questions
What is Aztreonam-Avibactam?
It's a new antibiotic specially designed to fight severe infections caused by bacteria that are very resistant to many other common antibiotics.
Will I have to take extra medication if I'm in the study?
No. You'd only be included in the study if your doctors have already decided that Aztreonam-Avibactam is the best treatment for your infection as part of your regular care.
Does being in the study mean I'll have more hospital visits?
No, this study only collects information from your existing medical records and care. It won't involve any extra appointments or visits for you.
Who can see my personal information?
The study team will protect your privacy. They will only use necessary information from your medical records, and your name or other identifying details won't be shared in study reports.
Can I choose not to be part of the study?
Yes, absolutely. If you prefer not to have your medical information included, just let your care team know, and it won't affect your treatment in any way.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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