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Status unknownNCT03868969FOSF'HOMUpdated Mar 11, 2019

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)

A Phase 2 interventional study of Fosfomycin Oral Suspension in Urinary Tract Infections, sponsored by Centre Hospitalier Universitaire de Besancon. Status unknown at 1 site in France. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-11.

Sponsored by Centre Hospitalier Universitaire de Besancon · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study 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

02

Conditions studied

  • Urinary Tract Infections
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 25 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Fosfomycin

    Fosomycin tromethamine, one sachet for 21 days

    Drug: Fosfomycin Oral Suspension

Interventions

  • DrugFosfomycin Oral Suspension

    Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days

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What researchers measure

Primary outcomes

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

    Number of patients with no signs of urinary tract infection

    Time frame: 28 days

Secondary outcomes

  1. Number of patients with persistence of clinical signs of urinary tract infection

    Number of patients with persistence of clinical signs of urinary tract infection

    Time frame: 3 days

  2. 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

    Time frame: 3 months

  3. Number of patients with digestive, cutaneous disturbance

    Number of patients with digestive, cutaneous disturbance

    Time frame: 28 days

07

Study locations

1 site
  • BOUILLER
    Besançon, 25000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03868969
Lead sponsor
Centre Hospitalier Universitaire de Besancon
Responsible party
Sponsor
First posted
Mar 11, 2019
Start date
Apr 2019 (estimated)
Primary completion
Apr 2021 (estimated)
Completion
Sep 2021 (estimated)
Last update
Mar 11, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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