Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT03868969
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03868969
Study Brief:
Protocol Section:
NCT03868969