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)

Phase 2

• Conditions: Urinary Tract Infections
• Interventions: Drug: Fosfomycin Oral Suspension

• Registration Number: NCT03868969
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-08
• Last Update Submitted: 2019-03-08
• Study First Posted: 2019-03-11
• Last Update Posted: 2019-03-11
• Study Start: 2019-04
• Primary Completion: 2021-04
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fosfomycin	Fosfomycin Oral Suspension	Fosomycin tromethamine, one sachet for 21 days

Primary Outcome Measures

Name	Time	Method
Number of patients with no signs of urinary tract infection	28 days	Number of patients with no signs of urinary tract infection

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

BOUILLER; 🇫🇷 Besançon, France