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NCT07176247: AZAVI
Real-world Multicentre Study of AZtreonam-AVIbactam Treatment With Infections or Suspected Infections Caused by Multidrug-resistant Gram-negative Bacteria
trial testing Aztreonam-Avibactam in Critical Care in 100 participants. Enrolling by invitation.
31 December 2027
Quick facts
| Lead sponsor | French Society for Intensive Care |
|---|---|
| Status | ENROLLING BY INVITATION |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 January 2024 |
| Primary completion | 31 December 2027 |
| Estimated completion | 31 December 2028 |
| Sites | 1 location across France |
Drugs / interventions tested
- Aztreonam-Avibactam — full drug profile →
Conditions studied
- Critical Care — all drugs for Critical Care →
- Infection — all drugs for Infection →
- Antibiotic Resistance — all drugs for Antibiotic Resistance →
- Infectious Diseases — all drugs for Infectious Diseases →
Sponsor
French Society for Intensive Care
Who can join
Eligibility, any sex, with Critical Care or Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07176247
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other French Society for Intensive Care trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07176247 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by French Society for Intensive Care
- Last refreshed: 16 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07176247.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing