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
1 other identifier
interventional
25
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedMarch 11, 2019
February 1, 2019
2 years
March 4, 2019
March 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of patients with no signs of urinary tract infection
Number of patients with no signs of urinary tract infection
28 days
Secondary Outcomes (3)
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
3 months
Number of patients with digestive, cutaneous disturbance
28 days
Study Arms (1)
Fosfomycin
EXPERIMENTALFosomycin tromethamine, one sachet for 21 days
Interventions
Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BOUILLER
Besançon, 25000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2019
First Posted
March 11, 2019
Study Start
April 1, 2019
Primary Completion
April 1, 2021
Study Completion
September 1, 2021
Last Updated
March 11, 2019
Record last verified: 2019-02