Status:
UNKNOWN
Clinical Efficacy of Fosfomycin Trometamol Per os in the Treatment of Documented Male Urinary Tract Infections With ESBL-producing Enterobacteriaceae With ESBL Producing Enterobacteriaceae and Resistance Associated With Fluoroquinolones and Cotrimoxazole (FOSF'HOM)
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Conditions:
Urinary Tract Infections
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 ent...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03868969
Start Date
April 1 2019
End Date
September 1 2021
Last Update
March 11 2019
Active Locations (1)
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1
BOUILLER
Besançon, France, 25000