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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