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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) (FOSF'HOM)

Primary Purpose

Urinary Tract Infections

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Fosfomycin Oral Suspension
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • BOUILLER

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fosfomycin

Arm Description

Fosomycin tromethamine, one sachet for 21 days

Outcomes

Primary Outcome Measures

Number of patients with no signs of urinary tract infection
Number of patients with no signs of urinary tract infection

Secondary Outcome Measures

Number of patients with persistence of clinical signs of urinary tract infection
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
Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis
Number of patients with digestive, cutaneous disturbance
Number of patients with digestive, cutaneous disturbance

Full Information

First Posted
March 4, 2019
Last Updated
March 8, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT03868969
Brief 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)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 2019 (Anticipated)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fosfomycin
Arm Type
Experimental
Arm Description
Fosomycin tromethamine, one sachet for 21 days
Intervention Type
Drug
Intervention Name(s)
Fosfomycin Oral Suspension
Intervention Description
Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days
Primary Outcome Measure Information:
Title
Number of patients with no signs of urinary tract infection
Description
Number of patients with no signs of urinary tract infection
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Number of patients with persistence of clinical signs of urinary tract infection
Description
Number of patients with persistence of clinical signs of urinary tract infection
Time Frame
3 days
Title
Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis
Description
Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis
Time Frame
3 months
Title
Number of patients with digestive, cutaneous disturbance
Description
Number of patients with digestive, cutaneous disturbance
Time Frame
28 days

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
BOUILLER
City
Besançon
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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)

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