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)

Centre Hospitalier Universitaire de Besancon

Status and phase

Unknown

Phase 2

Conditions

Urinary Tract Infections

Treatments

Drug: Fosfomycin Oral Suspension

Study type

Interventional

Funder types

Other

Identifiers

NCT03868969

API/2017/90

Details and patient eligibility

About

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

Enrollment

25 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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