Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections
NCT07725848 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200
Last updated 2026-07-24
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
Sponsors & Collaborators
-
IRCCS Azienda Ospedaliero-Universitaria di Bologna
lead OTHER
Principal Investigators
-
Cecilia Maria Bonazzetti, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-10-15
- Primary Completion
- 2028-04-30
- Completion
- 2029-10-15
Countries
- Italy
Study Locations
More Related Trials
-
Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase and/or AmpC β-lactamase Producing Enterobacteriaceae
NCT01138566 ·Status: UNKNOWN
-
Safety and Efficacy of ZTI-01 (IV Fosfomycin) vs Piperacillin/Tazobactam for Treatment cUTI/AP Infections
NCT02753946 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy and Safety Study of Short-term Antibiotic for Pyelonephritis in Women
NCT01390623 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of IV CXA-101 and IV Ceftazidime in Patients With Complicated Urinary Tract Infections
NCT00921024 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI (RESCUING)
NCT02641015 ·Status: COMPLETED
-
A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection
NCT07202949 ·Status: RECRUITING ·Phase: PHASE2
-
Impact of Specific Antimicrobials and MIC Values on the Outcome of Bloodstream Infections Due to ESBL- or Carbapenemase-producing Enterobacterales in Solid Organ Transplantation: an Observational Multinational Study.
NCT02852902 ·Status: COMPLETED
-
A Study to Assess the Safety, Tolerability and Efficacy of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-048)
NCT00379951 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
NCT00690378 ·Status: COMPLETED ·Phase: PHASE2
-
An Efficacy and Safety of Flomoxef Versus Cefepime in the Treatment of Participants With Urinary Tract Infections
NCT02302092 ·Status: TERMINATED ·Phase: PHASE3
-
Evaluation of the Non-inferiority of Cefoxitin Versus Imipenem/Cilastatin in the Treatment of Urinary Tract Infections Caused by ESBL-producing Escherichia Coli
NCT02474706 ·Status: TERMINATED ·Phase: PHASE4
-
Fosfomycin I.v. for Treatment of Severely Infected Patients
NCT02979951 ·Status: RECRUITING
-
An Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.
NCT01173068 ·Status: UNKNOWN
-
Study Evaluating Piperacillin/Tazobactam in Complicated Urinary Infections.
NCT00195286 ·Status: COMPLETED
-
PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE
NCT06717594 ·Status: RECRUITING
-
Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections
NCT01281462 ·Status: COMPLETED ·Phase: PHASE2
-
GSK2251052 in Complicated Urinary Tract Infection
NCT01381549 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy/Safety of Meropenem-Vaborbactam Compared to Piperacillin-Tazobactam in Adults With cUTI and AP
NCT02166476 ·Status: COMPLETED ·Phase: PHASE3
-
Multicentre Prospective Observational Cohort Study Aiming to Collect Medical Data, Create a Database to Facilitate Clinical and Fundamental Research Into Urinary Tract Infections With the Ultimate Goal of Improving Their Treatment.
NCT07485686 ·Status: ENROLLING_BY_INVITATION
-
Temocillin Versus Carbapenems for Urinary Tract Infection Due to ESBL-producing Enterobacteriaceae
NCT04671290 ·Status: COMPLETED
-
A Study to Assess Efficacy and Safety Intravenous Benapenem in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
NCT04505683 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study of Ceftolozane/Tazobactam (MK-7625A) in Japanese Participants With Uncomplicated Pyelonephritis and Complicated Urinary Tract Infection (MK-7625A-014)
NCT02728089 ·Status: COMPLETED ·Phase: PHASE3
-
Ertapenem in Patients With Urosepsis
NCT03859362 ·Status: UNKNOWN ·Phase: PHASE4
-
Carbapenem-resistant Enterobacteriaceae: Prevalence, Risk Factors and Impact of the Use of the Phenotypic Algorithm for the Detection of Carbapenemases
NCT02127450 ·Status: COMPLETED
-
Urinary Tract Infections Caused by Extended-spectrum Beta-lactamase-producing Enterobacteria
NCT06910878 ·Status: RECRUITING