Bacteremic urinary tract infection by Escherichia coli extended spectrum beta-lactamase (ESBL). MedDRA version: 16.1 Level: PT Classification code 10052238 Term: Escherichia urinary tract infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Disodium Fosfomycin
Product Name: Fosfomycin
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Fosfomyc
Sponsors
FISEVI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * Adult (over 18) hospitalized patients diagnosed with bacteremia due to urinary tract infection by E. coli extended spectrum beta-lactamase (ESBL). *Isolation of this microorganism in blood culture with clinical sepsis without other obvious or the most likely origin of the urinary bacteremia. *Required intravenous treatment during 5 days at least. *Women of childbearing potential must have a negative pregnancy test. *Signed informed consent form. 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: *Polymicrobial bacteremia. *Undrained renal abscess or not resolved urinary tract obstruction. *Prostatitis. *Haematogenous or contiguous urinary infection *Concomitant infections *Polycystic kidney disease. *Renal trasplantation. *Allergy or hypersensitivity to fosfomycin or meropenem. *Terminal condition, or life expectancy less than 90 days, or palliative treatment of the underlying disease. *Delayed inclusion > 12 hours since the identification of E. coli ESBL in blood culture. *Patients participating in other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: *To evaluate the early clinical and microbiological response in both arms. * To compare mortality and hospitalization period in the first 30 days, in patients treated with fosfomycin and meropenem. *To evaluate the safety of intravenous fosfomycin in this treatment. *To compare recurrent episodes rate(relapse or reinfection) in both arms. *Pharmacokinetics of intravenous fosfomycin in patients with bacteremic urinary tract infection by E. coli extended spectrum beta-lactamase (ESBL). *To compare the impact of fosfomycin and meropenem about the colonization in the intestinal tract by multiresistant gram-negative bacilli. *To assess the frequency of emergence resistant strains to fosfomycin and the resistance mechanisms involved. ;Main Objective: The main objective of this study is to evaluate the efficacy of intravenous fosfomycin with regard to meropenem for the treatment of bacteremic urinary tract infections caused by E. coli ESBL.;Primary end point(s): Clinical and microbiological cure occurring at 5?7 days after the end of the treatment.;Timepoint(s) of evaluation of this end point: At 5?7 days after the end of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): *Early clinical recovery. *Early microbiological recovery. *Recurrent episodes (relapse or reinfection) in the fisrt 60 days. *Mortality in the first 30 days and hospitalization period. *Frecuency and seriousness of adverse events. *Fosfomycin plasmatic concentration in stationary phase (day 3). *Ratio of E. coli resistant to fosfomycin and meropenem during the treatment ; Timepoint(s) of evaluation of this end point: *Day 3 (Visit 2) *Day 5 (Visit 3) *Day 5-7 (Visit 4) *In the first 30 days *In the first 60 days | — |
Countries
Spain
Contacts
Public ContactJesús Rodríguez Baño
Andalusian Health Service
Outcome results
None listed