Clinical Efficacy of Fosfomycin Trometamol Per os in the... | NCT03868969

Studies
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)

NCT03868969

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Unknown status

Last Update Posted

Mar 11, 2019Actual

Enrollment

25Estimated

Phase

Phase 2

Conditions

Urinary Tract Infections

Interventions

Fosfomycin Oral Suspension

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2019Estimated

Primary Completion Date

Apr 2021Estimated

Completion Date

Sep 2021Estimated

First Submitted Date

Mar 4, 2019

First Submission Date that Met QC Criteria

Mar 8, 2019

First Posted Date

Mar 11, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2019

Last Update Posted Date

Mar 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fosfomycin	Experimental	Fosomycin tromethamine, one sachet for 21 days	Drug: Fosfomycin Oral Suspension

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fosfomycin Oral Suspension	Drug	Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days	Fosfomycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with no signs of urinary tract infection	Number of patients with no signs of urinary tract infection	28 days

Secondary Outcomes

Measure	Description	Time Frame
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
Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
BOUILLER		Besançon		25000	France

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases