Fosfomycin for Complicated urinary tract infection

Inclusion criteria

• {"criterion_text":"- cUTI, in adult patients, defined as the presence of signs or symptoms, pyuria, and growth of cephalosporin-non-susceptible, fosfomycin susceptible Enterobacterales in urine (a positive urine culture of 105 colony-forming units (CFU)/ml)."}

Exclusion criteria

• {"criterion_text":"- Hemodynamical instability in the last 24 hours"}
• {"criterion_text":"- Alternative source of infection explaining the fever according to physician’s judgement"}
• {"criterion_text":"- Prostatitis, orchitis, or epididymitis"}
• {"criterion_text":"- Urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period (except surgery required to relieve an obstruction or place a stent or nephrostomy prior to EOT)"}
• {"criterion_text":"- pregnancy and/or breastfeeding"}

Primary endpoints

• {"endpoint_text":"- Clinical Response (CR) defined as clinical and microbiological cure (CMC) at 5 to 7 days after finalization of treatment (test of cure, TOC)","definition_or_measurement_approach":"Clinical and microbiological cure (CMC) assessed at 5 to 7 days after finalisation of treatment (test of cure, TOC)."}

Secondary endpoints

• {"endpoint_text":"- Clinical cure rates in the 2 treatment groups in MITT, m-MITT, clinical evaluable, and microbiologic evaluable populations at TOC","definition_or_measurement_approach":"Clinical cure rates compared between treatment groups in MITT, m-MITT, clinical evaluable, and microbiologic evaluable populations at test-of-cure (TOC)."}
• {"endpoint_text":"- clinical evaluation after 48 h from first drug administration","definition_or_measurement_approach":"Clinical evaluation performed 48 hours after first drug administration."}
• {"endpoint_text":"- microbiological eradication rates in m-MITT and ME populations at TOC","definition_or_measurement_approach":"Microbiological eradication rates assessed in m-MITT and microbiologic evaluable (ME) populations at TOC."}
• {"endpoint_text":"- Mortality for any reason until day 30","definition_or_measurement_approach":"All-cause mortality measured up to day 30."}
• {"endpoint_text":"- Hospital readmissions or extended hospitalization","definition_or_measurement_approach":"Occurrence of hospital readmissions or extended hospitalization (timeframe not further specified here)."}
• {"endpoint_text":"- Number of hospital re-admissions until day 90","definition_or_measurement_approach":"Count of hospital re-admissions occurring up to day 90."}
• {"endpoint_text":"- Relapse or reinfections","definition_or_measurement_approach":"Occurrence of relapse or reinfection events (definitions as per protocol; not further specified in CTIS extract)."}
• {"endpoint_text":"- Clostridioides difficile associated diarrhea","definition_or_measurement_approach":"Incidence of C. difficile associated diarrhea (case definition per protocol; not detailed in CTIS extract)."}
• {"endpoint_text":"- AE related to fosfomycin treatment","definition_or_measurement_approach":"Adverse events judged related to fosfomycin treatment (assessed and recorded per protocol)."}

Italy

Earliest CTIS Part Ii Submission Date

09-10-2024

Latest Decision Or Authorization Date

12-11-2024

Processing Time Days

34

Number Of Sites

3

Number Of Participants

548

Primary sponsor

Full Name

Azienda Ospedaliero Universitaria Di Modena

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy