Complicated Urinary Tract InfectionsCP-CUTINCT07725848
Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections
An observational study of Complicated Urinary Tract Infections and Antibiotic Resistance, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.
Trial summary
This study is designed to better understand how well a new antibiotic combination, cefepime/enmetazobactam (FEP/META), works in patients with complicated urinary tract infections that have spread to the bloodstream (bacteremia). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Urinary Tract Infections, Antibiotic Resistance
- How many people
- 200 participants
- Where
- 3 sitesItaly
- Study dates
- 15 Oct 2026to 15 Oct 2029
- 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 (age ≥ 18 years) patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT
Who may be able to join
- Patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT
- Adult population (age ≥ 18 years)
- Signed informed consent form
Who cannot join
- Polymicrobial/mixed infections (Gram-positive bacteria or fungi together with Gram-negative microorganisms), except in cases involving multiple Gram-negative bacteria susceptible to the study drugs
- Patients with negative blood cultures
- Isolation of Gram-negative microorganisms not susceptible to the study drugs (e.g., KPC-producing organisms)
- Patients in palliative care or with a high likelihood of death within 72 hours from the index positive blood culture
- Patients treated with inappropriate therapy for more than 48 hours
- Patients discharged early without follow-up blood cultures
- History of significant hypersensitivity or allergic reactions to cefepime, to any of the excipients in the respective formulations, or to beta-lactamase inhibitors (e.g., tazobactam)
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Cecilia Maria Bonazzetti, MD, +39 051 214 3595, cecilia.bonazzetti@unibo.it
Cecilia Maria Bonazzetti, MD
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) Garibaldi
Catania, Italy, 95122
Federica Cosentino, MD, +39 0957594936, fcosentino@arnasgaribaldi.it
Federica Cosentino, MD
ASST Fatebenefratelli Sacco
Milan, Italy, 20157
Matteo Passerini, MD, +39 02 6363 4967, passerini.matteo@asst-fbf-sacco.it
Matteo Passerini, MD
About this study
Official title: Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections: an Observational Prospective Study
This study is designed to better understand how well a new antibiotic combination, cefepime/enmetazobactam (FEP/META), works in patients with complicated urinary tract infections that have spread to the bloodstream (bacteremia). These infections are caused by bacteria that are resistant to several commonly used antibiotics, including bacteria that produce extended-spectrum beta-lactamases (ESBLs) or OXA-48 carbapenemases.
The main goal of the study is to compare cefepime/enmetazobactam with the best currently available antibiotic treatments to see how quickly blood cultures become negative after treatment begins, which is an important sign that the infection is improving.
Read the detailed description
The study aims to evaluate the time to blood culture negativization in patients treated with cefepime/enmetazobactam (FEP/META), a drug recently introduced into clinical practice, compared with the best available therapy (BAT) for targeted treatment of complicated urinary tract infections with bacteremia caused by microorganisms harboring specific antibiotic resistance mechanisms (extended-spectrum beta-lactamase producers and OXA-48-type carbapenemase producers).
This is an investigator-initiated, observational, pharmacological, prospective multicenter cohort study that will enroll one hundred patients with urinary tract infection and bacteremia treated with cefepime/enmetazobactam, and an equal number treated with the best currently available antibiotic therapy.
Among the secondary objectives, the study aims to investigate clinical cure (defined as complete resolution of the signs and symptoms present at the time of screening) between the two groups, mortality at day 30 and day 90, the safety of cefepime/enmetazobactam, differences between the two groups in the trends of biological biomarkers, and differences in relapse rates between the two groups.
- Keywords
- Complicated Urinary Tract Infections, Cefepime/Enmetazobactam (FEP/META), Bacteremia, Antibiotic Resistance, Beta-lactamase Producers, OXA-48-type Carbapenemase Producers
- Medical subject headings
- Bacteremia
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 |
|---|---|---|
| Patients with complicated urinary tract infections with bacteremia caused by resistant bacteria | Patients treated with cefepime/enmetazobactam (FEP/META), a drug recently introduced into clinical practice in Italy, compared with the best available therapy (BAT) for targeted treatment of complicated urinary tract infections with bacteremia caused by microorganisms harboring specific antibiotic resistance mechanisms (extended-spectrum beta-lactamase producers and OXA-48-type carbapenemase producers). |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the timing of microbiological eradication
To evaluate the timing of microbiological eradication in patients who received cefepime/enmetazobactam (FEP/META) compared to best available therapy (BAT) for targeted treatment of bacteremic complicated urinary tract infections (cUTIs) due to ESBL/OXA48 producers Gram-negatives
Measured: Within two weeks from the antibiotic therapy initiation
Secondary outcomes (1)
To investigate clinical cure
To investigate clinical cure (defined as complete resolution of baseline signs and symptoms present at screening) at day 3-7 after positive blood culture between two groups
Measured: At day 3-7 after positive blood culture between two groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Oct 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion15 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Maria Bonazzetti, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725848
- Sponsor's protocol ID
- CP-CUTI
- Other IDs
- 3438
- Acronym
- CP-CUTI
- Status last verified
- Jul 2026
- First submitted
- 11 Jun 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections: an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT07725848
- Acronym / sponsor ID
- CP-CUTI / CP-CUTI
- Keywords
- Complicated Urinary Tract Infections, Cefepime/Enmetazobactam (FEP/META), Bacteremia, Antibiotic Resistance, Beta-lactamase Producers, OXA-48-type Carbapenemase Producers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 15 Oct 2029 (estimated)
- First posted
- 24 Jul 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.
This study is designed to better understand how well a new antibiotic combination, cefepime/enmetazobactam (FEP/META), works in patients with complicated urinary tract infections that have spread to the bloodstream (bacteremia). These infections are caused by bacteria that are resistant to several commonly used antibiotics, including bacteria that produce extended-spectrum beta-lactamases (ESBLs) or OXA-48 carbapenemases.
The main goal of the study is to compare cefepime/enmetazobactam with the best currently available antibiotic treatments to see how quickly blood cultures become negative after treatment begins, which is an important sign that the infection is improving.
Detailed description
The study aims to evaluate the time to blood culture negativization in patients treated with cefepime/enmetazobactam (FEP/META), a drug recently introduced into clinical practice, compared with the best available therapy (BAT) for targeted treatment of complicated urinary tract infections with bacteremia caused by microorganisms harboring specific antibiotic resistance mechanisms (extended-spectrum beta-lactamase producers and OXA-48-type carbapenemase producers).
This is an investigator-initiated, observational, pharmacological, prospective multicenter cohort study that will enroll one hundred patients with urinary tract infection and bacteremia treated with cefepime/enmetazobactam, and an equal number treated with the best currently available antibiotic therapy.
Among the secondary objectives, the study aims to investigate clinical cure (defined as complete resolution of the signs and symptoms present at the time of screening) between the two groups, mortality at day 30 and day 90, the safety of cefepime/enmetazobactam, differences between the two groups in the trends of biological biomarkers, and differences in relapse rates between the two groups.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with complicated urinary tract infections with bacteremia caused by resistant bacteria | – | –Patients treated with cefepime/enmetazobactam (FEP/META), a drug recently introduced into clinical practice in Italy, compared with the best available therapy (BAT) for targeted treatment of complicated urinary tract infections with bacteremia caused by microorganisms harboring specific antibiotic resistance mechanisms (extended-spectrum beta-lactamase producers and OXA-48-type carbapenemase producers). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult (age ≥ 18 years) patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT
Key inclusion criteria (3 listed)
- Patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT
- Adult population (age ≥ 18 years)
- Signed informed consent form
Key exclusion criteria (7 listed)
- Polymicrobial/mixed infections (Gram-positive bacteria or fungi together with Gram-negative microorganisms), except in cases involving multiple Gram-negative bacteria susceptible to the study drugs
- Patients with negative blood cultures
- Isolation of Gram-negative microorganisms not susceptible to the study drugs (e.g., KPC-producing organisms)
- Patients in palliative care or with a high likelihood of death within 72 hours from the index positive blood culture
- Patients treated with inappropriate therapy for more than 48 hours
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
To evaluate the timing of microbiological eradication
Time frame: Within two weeks from the antibiotic therapy initiation
To evaluate the timing of microbiological eradication in patients who received cefepime/enmetazobactam (FEP/META) compared to best available therapy (BAT) for targeted treatment of bacteremic complicated urinary tract infections (cUTIs) due to ESBL/OXA48 producers Gram-negatives
1 secondary outcome
To investigate clinical cure
Time frame: At day 3-7 after positive blood culture between two groups
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 24 Jul 2026.
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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.
Cecilia Maria Bonazzetti, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Urinary Tract Infections and Antibiotic Resistance, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 3 sites in Italy.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Contact Cecilia Maria Bonazzetti, MD (+390512143595, cecilia.bonazzetti@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the timing of microbiological eradication (time frame: Within two weeks from the antibiotic therapy initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.