Urinary Tract Infections
Conditions
Brief summary
The aim of the study was to evaluate the clinical and microbiological efficacy of fosfomycin trometamol (FT) per os in the treatment of documented male urinary tract infections with ESBL-producing enterobacteriaceae
Interventions
Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* clinical suspicion of urinary tract infection (UTI) defined by the presence of at least one of these signs: fever \> 38°C and/or sus-pubic pain and/or dysuria and/or pollakiuria and/or urinary burns and/or macroscopic hematuria and/or acute urinary retention and/or pain with the rectal examination and/or confusion * And urinary analysis with leukocyturia \> 10 / mm3, bacteriuria \> 10\^3 CFU/mL with ESBL producing enterobacteriaceae and resistance associated with fluoroquinolones (FQ) and cotrimoxazole (CTX) but sensitive to fosfomycin.
Exclusion criteria
* allergy to fosfomycin and/or trometamol * Presence of material in the urinary tract * Severe immunosuppression * Chronic prostatitis * Prostate abscess * Acute pyelonephritis * Hemodynamic instability * Chronic renal failure (clearance \<60 mL/min) * Prior antibiotic therapy, with an antibiotic sensitive on the antibiotic susceptibility test except: amoxicillin - clavulanic acid, cefixime, nitrofurantoin. * Co-treatment with metoclopramide
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with no signs of urinary tract infection | 28 days | Number of patients with no signs of urinary tract infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with digestive, cutaneous disturbance | 28 days | Number of patients with digestive, cutaneous disturbance |
| Number of patients with persistence of clinical signs of urinary tract infection | 3 days | Number of patients with persistence of clinical signs of urinary tract infection |
| Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis | 3 months | Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis |
Countries
France
Outcome results
None listed