Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT
Adult population (age ≥ 18 years)
Signed informed consent form
Disqualifiers
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
Trial population
Adult (age ≥ 18 years) patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Patients with complicated urinary tract infections with bacteremia caused by resistant bacteria
Trial outcomes
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
Time frame
Within two weeks from the antibiotic therapy initiationSecondary 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
Time frame
At day 3-7 after positive blood culture between two groupsOther outcomes
1
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 therapy2
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 therapy3
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 therapy4
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 therapySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: