Real-world Multicentre Study of AZtreonam-AVIbactam Treatment With Infections or Suspected Infect… (NCT07176247) | Clinical Trial Compass
By InvitationNot Applicable
Real-world Multicentre Study of AZtreonam-AVIbactam Treatment With Infections or Suspected Infections Caused by Multidrug-resistant Gram-negative Bacteria
France100 participantsStarted 2024-01-01
Plain-language summary
The AZAVI study is a multicenter observational registry (ICU and Infectious Diseases departments), designed to evaluate the real-world use of aztreonam-avibactam for suspected or documented infections caused by metallo-β-lactamase (MBL)-producing Enterobacterales or highly resistant Gram-negative bacteria. The study combines a retrospective cohort (patients treated during the 12 months prior to the drug's hospital availability) and a prospective cohort (patients consecutively included over 24 months).
The primary outcome is clinical success at day 7 after antibiotic discontinuation, defined as resolution of signs and symptoms of infection without recurrence or need for additional active therapy. Secondary outcomes include microbiological eradication, 14-day and 28-day all-cause mortality, infection relapse, length of stay, safety outcomes, and predictors of treatment failure.
Data will be collected using a standardized CRF, including demographics, severity scores, infection site and pathogens, therapeutic regimens, organ failures and support, adverse events, and outcomes. Descriptive statistics and multivariable models will be used to assess real-world effectiveness, identify determinants of clinical response, and inform stewardship strategies. This registry will provide the first national-scale evidence on the role of aztreonam-avibactam in critically ill patients outside the framework of controlled clinical trials.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Hospitalized patients with suspected or documented infection due to MBL-producing bacteria, treated with ATM-AVI.
Exclusion Criteria:
* Explicit refusal by patient or legal representative.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1My infection is being treated in a critical care setting — is the bacteria causing it the type of multidrug-resistant gram-negative bacteria that this real-world study is specifically looking at, and would my case even be considered for inclusion?
2Since this study is 'enrolling by invitation only,' does that mean my care team would need to proactively refer me, and is that something you're connected to or able to facilitate?
3This is a real-world observational study rather than a controlled clinical trial — does that mean I would be receiving aztreonam-avibactam as my actual treatment regardless of the study, and that the study is mainly tracking how patients like me do in practice?
4The study measures 'clinical success' seven days after finishing the antibiotic course — what does that outcome actually mean for my specific situation, and how would my doctors know if the treatment is working before that point?
5Given that aztreonam-avibactam is being studied precisely because standard antibiotics may not work against multidrug-resistant infections, are there any other treatment options still available to me, and how does this antibiotic compare to what I might otherwise receive?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical success at the test-of-cure visit (day 7 after completion of initial antibiotic therapy)
Timeframe: day 7 after completion of initial antibiotic therapy