Oral Fosfomycin versus Ciprofloxacin for Febrile Urinary Tract Infection in Men: a pilot study

one0 个研究点目标入组 30 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

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•1. Competent male patient aged 18 years or above
•2. One or more symptom(s) suggestive of urinary tract infection (dysuria, frequency or
•urgency; perineal or suprapubic pain; costo-vertebral tenderness or flank pain)
•3. Fever (ear or rectal temp of 38.2 oC or higher, or axillary temp of 38 oC or higher), or
•history of feeling feverish with shivering or rigors in the past 24 hours
•4. Positive urine nitrate test and/or leucocyturia as depicted by positive leukocyte
•esterase test or microscopy
•5. Hospital admission for presumed FUTI and empirical intravenous antibiotic treatment
•with beta-lactams
•6. Positive urine (> 103 CFU/ml) culture and/or blood culture with E. coli susceptible to
•fosfomycin, ciprofloxacin and the empirical intravenous beta-lactam treatment
•7. Fullfilment of criteria for safe iv to oral switch (hemodynamic stability, ability to
•consume oral antibiotics, no gastrointestinal problems which affect absorption)

•1. Known allergy to fosfomycin or ciprofloxacin
•2. Patients with known polycystic kidney disease
•3. Patients on permanent renal replacement therapy (hemodialysis or peritoneal
•4. Patients with history of kidney transplantation
•5. Patients with a permanent urinary catheter
•6. Patients with chronic renal failure (eGFR < 30 ml/min/1.73m3)
•7. Patients with renal abcess or pyonephrosis
•8. Patients with chronic bacterial prostatitis (defined as recurrent UTI with the same
•uropathogen and no other clarifying underlying urological disorder)
•9. Patients with any diagnosed metastatic E. coli foci
•10. Patients with a double-J or nephrostomy catheter
•11. Concomitant systemic antibiotic treatment for another reason than FUTI
•12. Residence outside the Netherlands
•13. Inability to speak or read Dutch
•Specific exclusion criteria for the FOS-MEN-pharm substudy is
•1. Incontinency for urine, which results in the inability to properly get urine samples.

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