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)
NCT ID: NCT03868969
Last Updated: 2019-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
25 participants
INTERVENTIONAL
2019-04-30
2021-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fosfomycin
Fosomycin tromethamine, one sachet for 21 days
Fosfomycin Oral Suspension
Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days
Interventions
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Fosfomycin Oral Suspension
Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
MALE
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Locations
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BOUILLER
Besançon, , France
Countries
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Other Identifiers
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API/2017/90
Identifier Type: -
Identifier Source: org_study_id
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