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

Intravenous Fosfomycin in hospitalized patients with complicated urinary tract infections due to Third-generation cephalosporinresistant Enterobacterales. - FOSFO3GCRE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2023-000052-38-IT

Enrollment

370

Registered

2023-01-30

Start date

2023-06-26

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

urinary tract infections MedDRA version: 20.0 Level: LLT Classification code 10046849 Term: UTI symptoms System Organ Class: 100000004862

Interventions

Pharmaceutical Form: Powder for infusion INN or Proposed INN: FOSFOMICINA CAS Number: 23155-02-4 Current Sponsor code: IMP-1 Other descriptive name: Fosfomycin Concentration unit: mg/ml milligram(s)/m

Eligibility

Sex/Gender

All

Inclusion criteria

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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 185 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 185

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the non-inferiority of IV fosfomycin compared to the best available therapy according to current clinical practice/choice;Secondary Objective: i) to describe the MIC distribution of isolates against all the study drugs by gold standard methods (i.e. agar dilution for fosfomycin and broth microdilution for alternative drugs) and investigate their correlation with clinical outcome; ii) to describe the main mechanisms of cephalosporin resistance in the isolates obtained from the blood cultures of patients with bacteremic cUTI by whole genome sequencing (WGS) and analyze their correlation with clinical outcome iii) to investigate the impact of PK/PD target attainment with clinical outcome; iv) to evaluate changes in the gut microbiota in patients with cUTIs and to compare the impact of each type of antibiotic therapy on the gut microbiota. Fecal microbial DNA will be extracted and subsequently analyzed by sequencing of the V3-V4 regions of the 16S ribosomal RNA gene.;Primary end point(s): Clinical Response (CR) defined as clinical and microbiological cure (CMC) at 5 to 7 days after finalization of treatment (test of cure, TOC);Timepoint(s) of evaluation of this end point: 5 to 7 days after finalization of treatment	—

Measure

Time frame

Main Objective: To investigate the non-inferiority of IV fosfomycin compared to the best available therapy according to current clinical practice/choice;Secondary Objective: i) to describe the MIC distribution of isolates against all the study drugs by gold standard methods (i.e. agar dilution for fosfomycin and broth microdilution for alternative drugs) and investigate their correlation with clinical outcome; ii) to describe the main mechanisms of cephalosporin resistance in the isolates obtained from the blood cultures of patients with bacteremic cUTI by whole genome sequencing (WGS) and analyze their correlation with clinical outcome iii) to investigate the impact of PK/PD target attainment with clinical outcome; iv) to evaluate changes in the gut microbiota in patients with cUTIs and to compare the impact of each type of antibiotic therapy on the gut microbiota. Fecal microbial DNA will be extracted and subsequently analyzed by sequencing of the V3-V4 regions of the 16S ribosomal RNA gene.;Primary end point(s): Clinical Response (CR) defined as clinical and microbiological cure (CMC) at 5 to 7 days after finalization of treatment (test of cure, TOC);Timepoint(s) of evaluation of this end point: 5 to 7 days after finalization of treatment

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Countries

Italy

Contacts

Public ContactUfficio Sperimentazioni Cliniche

Azienda Ospedaliero-Universitaria di Modena

nb.protocolli@unimore.it

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026