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

Haga Teaching Hospital0 个研究点目标入组 30 人开始时间: 2019年5月13日最近更新: 2023年9月4日

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 -lactams
•6.Positive urine (> 103 CFU/ml) culture and/or blood culture with E. coli susceptible to fosfomycin, ciprofloxacin and the empirical intravenous -lactam treatment
•7.Fulfilment of criteria for safe iv to oral switch (hemodynamic stability, ability to consume oral antibiotics, no gastrointestinal problems which affect absorption)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range 15
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1.Known allergy to fosfomycin or ciprofloxacin
•2.Patients with known polycystic kidney disease
•3.Patients on permanent renal replacement therapy (hemodialysis or peritoneal dialysis)
•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

发起方

Haga Teaching Hospital