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 Cotrimox

• Status: Unknown status
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Treatments: Fluoroquinolones; Fosfomycin; Trimethoprim, Sulfamethoxazole Drug Combination

Criteria

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