An observational study in Complicated Urinary Tract Infections and Antibiotic Resistance, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Not yet recruiting at 3 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
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.
297 studies on the registry are indexed under Bacteremia; 51 are open to participants now.
This study's planned enrollment of 200 is below the median of 300 across 125 observational studies indexed under Bacteremia.
Browse Bacteremia studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
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Adult (age ≥ 18 years) patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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
Time frame: Within two weeks from the antibiotic therapy initiation
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
Time frame: At day 3-7 after positive blood culture between two groups
To evaluate mortality at day 30 and day 90
All-cause mortality at day 30 and at day 90, after initiation of therapy, between two groups
Time frame: At day 30 and at day 90, after initiation of therapy
Difference in C-reactive protein (CRP) at Day 7
To investigate the difference between the two study groups in C-reactive protein (CRP) levels at Day 7 after initiation of therapy
Time frame: At day 7 after initiation therapy
Difference in procalcitonin (PCT) at Day 7
To investigate the difference between the two study groups in procalcitonin (PCT) levels at Day 7 after initiation of therapy
Time frame: At day 7 after initiation therapy
To investigate differences in recurrence rates between the two groups
Relapse (new infection with the same pathogen emerging after treatment) and/or Reinfection (new infection with a different pathogen emerging after treatment) rates at day 30 and 90 between two groups
Time frame: At day 30 and 90 after initiation therapy
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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