Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections

NCT07725848 | Not Yet Recruiting

• 2 other identifiers: CP-CUTI3438
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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). 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.

Conditions

Complicated Urinary Tract Infections; Antibiotic Resistance

Keywords

Complicated Urinary Tract Infections; Cefepime/Enmetazobactam (FEP/META); Bacteremia; Antibiotic Resistance; Beta-lactamase Producers; OXA-48-type Carbapenemase Producers

Outcome Measures

Primary Outcomes (1)

• 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

  Within two weeks from the antibiotic therapy initiation

Secondary Outcomes (1)

• To investigate clinical cure

  At day 3-7 after positive blood culture between two groups

Other Outcomes (4)

• To evaluate mortality at day 30 and day 90

  At day 30 and at day 90, after initiation of therapy

• Difference in C-reactive protein (CRP) at Day 7

  At day 7 after initiation therapy

• Difference in procalcitonin (PCT) at Day 7

  At day 7 after initiation therapy

Study Arms (1)

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).

Eligibility Criteria

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

Study Population

Adult (age ≥ 18 years) patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT

You may qualify if:

• Patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT
• Adult population (age ≥ 18 years)
• Signed informed consent form

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (3)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy, 40138, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) Garibaldi

Catania, Italy, 95122, Italy

Location

ASST Fatebenefratelli Sacco

Milan, Italy, 20157, Italy

Location

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cecilia Maria Bonazzetti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia Maria Bonazzetti, MD

CONTACT

+390512143595; cecilia.bonazzetti@unibo.it

Maddalena Giannella, MD, PhD

CONTACT

+390512143199; maddalena.giannella@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: July 24, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): October 15, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

IT (3)