Intravenous Fosfomycin in hospitalized patients with complicated urinary tract infections due to Third-generation cephalosporinresistant Enterobacterales

Phase 4

Not yet recruiting

• Conditions: urinary tract infections

• Registration Number: 2024-516591-15-00
• Lead Sponsor: Azienda Ospedaliero Universitaria Di Modena

Brief Summary

To investigate the non-inferiority of IV fosfomycin compared to the best available therapy according to current clinical practice/choice

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-11-12
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 548

Inclusion Criteria

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

Hemodynamical instability in the last 24 hours - Alternative source of infection explaining the fever according to physician’s judgement - Prostatitis, orchitis, or epididymitis - 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) - pregnancy and/or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Response (CR) defined as clinical and microbiological cure (CMC) at 5 to 7 days after finalization of treatment (test of cure, TOC)		Clinical Response (CR) defined as clinical and microbiological cure (CMC) at 5 to 7 days after finalization of treatment (test of cure, TOC)

Secondary Outcome Measures

Name	Time	Method
Clinical cure rates in the 2 treatment groups in MITT, m-MITT, clinical evaluable, and microbiologic evaluable populations at TOC;clinical evaluation after 48 h from first drug administration;microbiological eradication rates in m-MITT and ME populations at TOC;Mortality for any reason until day 30;Hospital readmissions or extended hospitalization; Number of hospital re-admissions until day 90;Relapse or reinfections;Clostridioides difficile associated diarrhea;AE related to fosfomycin treatment		Clinical cure rates in the 2 treatment groups in MITT, m-MITT, clinical evaluable, and microbiologic evaluable populations at TOC;clinical evaluation after 48 h from first drug administration;microbiological eradication rates in m-MITT and ME populations at TOC;Mortality for any reason until day 30;Hospital readmissions or extended hospitalization; Number of hospital re-admissions until day 90;Relapse or reinfections;Clostridioides difficile associated diarrhea;AE related to fosfomycin treatment

Trial Locations

Locations (3)

Azienda Ospedaliera Universitaria Federico II Di Napoli; 🇮🇹 Naples, Italy

Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico; 🇮🇹 Bologna, Italy

Azienda Ospedaliero Universitaria Di Modena; 🇮🇹 Modena, Italy

Azienda Ospedaliera Universitaria Federico II Di Napoli

🇮🇹Naples, Italy

Biagio Pinchera

Site contact

00390817463796

biagio.pinchera@unina.it