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)
Overview
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
Full Title of Study: “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)”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: April 2021
Interventions
- Drug: Fosfomycin Oral Suspension
- Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days
Arms, Groups and Cohorts
- Experimental: Fosfomycin
- Fosomycin tromethamine, one sachet for 21 days
Clinical Trial Outcome Measures
Primary Measures
- Number of patients with no signs of urinary tract infection
- Time Frame: 28 days
- Number of patients with no signs of urinary tract infection
Secondary Measures
- Number of patients with persistence of clinical signs of urinary tract infection
- Time Frame: 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
- Time Frame: 3 months
- Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis
- Number of patients with digestive, cutaneous disturbance
- Time Frame: 28 days
- Number of patients with digestive, cutaneous disturbance
Participating in This Clinical Trial
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
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- Provider of Information About this Clinical Study
- Sponsor
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