Metallo-β-lactamase-producingCEFAVINCT07911098
Real-world Effectiveness of Cefiderocol Versus Aztreonam/Avibactam
An observational study of Metallo-β-lactamase-producing, run by University Hospital Virgen de las Nieves at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metallo-β-lactamase-producing
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adult patients (≥18 years of age).
- Microbiologically confirmed infection caused by a metallo-β-lactamase (MBL)-producing Gram-negative bacterium.
- Treatment with cefiderocol or aztreonam-avibactam as part of routine clinical care.
- Receipt of the study antibiotic for at least 48 hours.
Who cannot join
- Patients younger than 18 years.
- Absence of microbiological confirmation of an MBL-producing Gram-negative bacterial infection.
- Treatment duration of less than 48 hours.
- Insufficient clinical or microbiological information to assess the primary outcome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Effectiveness of Cefiderocol Versus Aztreonam/Avibactam in Infections Caused by Metallo-β-lactamase-producing Gram-negative Bacteria
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.
Read the detailed description
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.
- Conditions
- Metallo-β-lactamase-producing
- Keywords
- cefiderocol, aztreonam-avibactam, metallo-β-lactamase-producing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cefiderocol therapy | Cefiderodol treatment at least 48 hours | |
| Aztreonam-avibactam therapy | Aztreonam-avibactam treatment at least 48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From treatment to 30-days
Secondary outcomes (3)
14-day mortality
mortality at day 14
Measured: 14 days
30-day mortality
mortality at day 30
Measured: 30 days
Microbiological eradication
Microbiological eradication if repeated culture
Measured: 78 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Jan 2024
- Primary completion10 May 2026
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metallo-β-lactamase-producingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Virgen de las Nieves
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro Manuel Garcia Ceberino, University Hospital Virgen de las Nieves
- Investigators
- Carmen Hidalgo-Tenorio, MD, PhD, Study director, University Hospital Virgen de las Nieves
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911098
- Sponsor's protocol ID
- CEFAVI-2026-001559
- Acronym
- CEFAVI
- Status last verified
- Sep 2026
- First submitted
- 22 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I have to review implications of this point
Publications
Torre-Cisneros J, Almirante B, Martos CF, Rascado P, Lleti MS, Sanchez-Garcia M, Soriano A, Soriano-Cuesta MC, Gonzalez Calvo AJ, Karas A, Sarda J, Verardi S, Ferrer R. Effectiveness and safety of cefiderocol treatment in patients with Gram-negative bacterial infections in Spain in the early access programme: results of the PERSEUS study. Eur J Clin Microbiol Infect Dis. 2025 Jun;44(6):1375-1390. doi: 10.1007/s10096-025-05108-6. Epub 2025 Mar 25.
PubMed 40131647
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness of Cefiderocol Versus Aztreonam/Avibactam in Infections Caused by Metallo-β-lactamase-producing Gram-negative Bacteria
- ClinicalTrials.gov ID
- NCT07911098
- Acronym / sponsor ID
- CEFAVI / CEFAVI-2026-001559
- Conditions
- Metallo-β-lactamase-producing
- Keywords
- cefiderocol, aztreonam-avibactam, metallo-β-lactamase-producing
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital Virgen de las NievesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefiderocol therapy | – | –Cefiderodol treatment at least 48 hours |
| Aztreonam-avibactam therapy | – | –Aztreonam-avibactam treatment at least 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Adult patients (≥18 years of age).
- Microbiologically confirmed infection caused by a metallo-β-lactamase (MBL)-producing Gram-negative bacterium.
- Treatment with cefiderocol or aztreonam-avibactam as part of routine clinical care.
- Receipt of the study antibiotic for at least 48 hours.
Key exclusion criteria (4 listed)
- Patients younger than 18 years.
- Absence of microbiological confirmation of an MBL-producing Gram-negative bacterial infection.
- Treatment duration of less than 48 hours.
- Insufficient clinical or microbiological information to assess the primary outcome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical cure or improvement at the end of treatment
Time frame: From treatment to 30-days
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.
3 secondary outcomes
14-day mortality
Time frame: 14 days
30-day mortality
Time frame: 30 days
Microbiological eradication
Time frame: 78 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Results publication: PubMed 40131647Torre-Cisneros J, Almirante B, Martos CF, Rascado P, Lleti MS, Sanchez-Garcia M, Soriano A, Soriano-Cuesta MC, Gonzalez Calvo AJ, Karas A, Sarda J, Verardi S, Ferrer R. Effectiveness and safety of cefiderocol treatment in patients with Gram-negative bacterial infections in Spain in the early access programme: results of the PERSEUS study. Eur J Clin Microbiol Infect Dis. 2025 Jun;44(6):1375-1390. doi: 10.1007/s10096-025-05108-6. Epub 2025 Mar 25.
- Individual participant dataSharing planned: Undecided. I have to review implications of this point
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Hidalgo-Tenorio, MD, PhD study director
University Hospital Virgen de las Nieves
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metallo-β-lactamase-producing, run by University Hospital Virgen de las Nieves at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure or improvement at the end of treatment (time frame: From treatment to 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07911098, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.