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)

March 8, 2019 updated by: Centre Hospitalier Universitaire de Besancon
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • BOUILLER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with no signs of urinary tract infection
Time Frame: 28 days
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
Time Frame: 3 days
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
Time Frame: 3 months
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
Time Frame: 28 days
Number of patients with digestive, cutaneous disturbance
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2019

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

March 4, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • API/2017/90

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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