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 Overview
=================
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

Official Title
-----------------
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)

Conditions
-----------------
Urinary Tract Infections

Intervention / Treatment
-----------------
* Drug: Fosfomycin Oral Suspension


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fosfomycin<br>Fosomycin tromethamine, one sachet for 21 days | Drug: Fosfomycin Oral Suspension<br>* Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with no signs of urinary tract infection | Number of patients with no signs of urinary tract infection | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with persistence of clinical signs of urinary tract infection | Number of patients with persistence of clinical signs of urinary tract infection | 3 days | 
| Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis | Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis | 3 months | 
| Number of patients with digestive, cutaneous disturbance | Number of patients with digestive, cutaneous disturbance | 28 days |