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)

Urinary Tract Infections Clinical Trial

— FOSF'HOM  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03868969
• Other study ID #: API/2017/90
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2019
• Est. completion date: September 2021

Study information

• Verified date: February 2019
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: September 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Drug:
• Fosfomycin Oral Suspension
Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days

Locations

Country	Name	City	State
France	BOUILLER	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with no signs of urinary tract infection	Number of patients with no signs of urinary tract infection	28 days
Secondary	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
Secondary	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
Secondary	Number of patients with digestive, cutaneous disturbance	Number of patients with digestive, cutaneous disturbance	28 days