Real-world Multicentre Study of AZtreonam-AVIbactam Treatment With Infections or Suspected Infections Caused by Multidrug-resistant Gram-negative Bacteria

NCT07176247 | Enrolling By Invitation

• 1 other identifier: CE-SRLF 25-034
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Care; Infection; Antibiotic Resistance; Infectious Diseases

Keywords

aztreonam; avibactam; critical care; infectiology; antibiotic; resistance; new betalactam; aztreonam-avibactam; real-world

Outcome Measures

Primary Outcomes (1)

• Clinical success at the test-of-cure visit (day 7 after completion of initial antibiotic therapy)

  Clinical success at the test-of-cure visit, day 7 after completion of the initial ATM-AVI regimen, defined as resolution of infection signs and symptoms without need for further active antibiotics. Death (any cause) and microbiologically confirmed relapse are considered treatment failures.

  day 7 after completion of initial antibiotic therapy

Secondary Outcomes (5)

• Microbiological eradication/persistence

  Day-28

• Mortality

  Mortality at day 28 and day 90

• Duration

  Day-28

• Adverse events attributable to ATM-AVI

  Day-28

• Patterns of monotherapy vs. combination therapy

  Day-28

Study Arms (1)

Hospitalized patients under Aztreonam-Avibactam

Drug: Aztreonam-Avibactam

Interventions

Aztreonam-Avibactam DRUG

Antibiotic therapy with Aztreonam-Avibactam

Hospitalized patients under Aztreonam-Avibactam

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with suspected or documented infection due to MBL-producing bacteria, treated with ATM-AVI.

You may qualify if:

• Hospitalized patients with suspected or documented infection due to MBL-producing bacteria, treated with ATM-AVI.

You may not qualify if:

• Explicit refusal by patient or legal representative.

Sponsors & Collaborators

• French Society for Intensive Care: lead
• SPILF: collaborator

Study Sites (1)

French Society of Intensive Care (SRLF)

Paris, France

Location

MeSH Terms

Conditions

Infections; Communicable Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: The datasets generated during and/or analyzed during the study are available from the corresponding author on reasonable request.

Locations

FR (1)