An observational study in Metallo-β-lactamase-producing, sponsored by University Hospital Virgen de las Nieves. Active, not recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University Hospital Virgen de las Nieves · Observational
CEFAVI is an observational study that compares the real-world effectiveness of two antibiotics, cefiderocol and aztreonam/avibactam, in patients with infections caused by Gram-negative bacteria that produce metallo-β-lactamases (MBLs). The study will collect and analyze clinical and microbiological information from patients treated with either antibiotic as part of routine clinical care. The aim is to better understand the effectiveness, microbiological response, and safety of these treatments in real-world clinical practice.
CEFAVI is a multicenter, observational, prospective, comparative study designed to evaluate the real-world effectiveness of cefiderocol compared with aztreonam/avibactam in patients with infections caused by metallo-β-lactamase (MBL)-producing Gram-negative bacteria.
The study will include patients with microbiologically confirmed infection caused by MBL-producing Gram-negative bacteria who receive cefiderocol or aztreonam/avibactam as part of routine clinical care. Treatment allocation will not be determined by the study protocol and will be based on the treating physician's clinical decision.
Clinical, microbiological, and treatment-related data will be collected prospectively from participating centers. Baseline characteristics, infection site, severity of illness, microbiological findings, antimicrobial susceptibility data, treatment characteristics, concomitant antimicrobial therapy, and relevant clinical outcomes will be recorded.
The primary objective is to compare the effectiveness of cefiderocol and aztreonam/avibactam in the treatment of infections caused by MBL-producing Gram-negative bacteria in real-world clinical practice. Secondary objectives include evaluating clinical and microbiological outcomes, mortality, microbiological eradication, recurrence, emergence of antimicrobial resistance, and treatment-related adverse events.
As an observational study, CEFAVI will not assign patients to a specific treatment or modify routine clinical management.
University Hospital Virgen de las Nieves is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with microbiologically confirmed infections caused by metallo-β-lactamase (MBL)-producing Gram-negative bacteria who receive cefiderocol or aztreonam/avibactam as part of routine clinical care at participating hospitals. The study population will include patients with different types and sites of infection and varying degrees of clinical severity.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Cefiderodol treatment at least 48 hours
Aztreonam-avibactam treatment at least 48 hours
Clinical cure or improvement at the end of treatment
Clinical effectiveness of cefiderocol versus aztreonam-avibactam, assessed at the end of treatment according to clinical response. Clinical cure is defined as resolution of signs and symptoms attributable to the infection, while clinical improvement is defined as a clinically meaningful improvement in infection-related signs and symptoms, without complete resolution. The outcome will be assessed using the available clinical records and documented clinical status at the end of treatment.
Time frame: From treatment to 30-days
14-day mortality
mortality at day 14
Time frame: 14 days
30-day mortality
mortality at day 30
Time frame: 30 days
Microbiological eradication
Microbiological eradication if repeated culture
Time frame: 78 hours
Plan to share: Undecided — I have to review implications of this point
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Virgen de las Nieves