NL-OMON55825招募中3 期
Oral Fosfomycin versus Ciprofloxacin for Febrile Urinary Tract Infection in Men: a pilot study - FOS-ME
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •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 b-lactams
- •6. Positive urine (> 103 CFU/ml) culture and/or blood culture with E. coli
- •susceptible to fosfomycin, ciprofloxacin and the empirical intravenous -lactam
- •7. Fulfilment of criteria for safe iv to oral switch (hemodynamic stability,
- •ability to consume oral antibiotics, no gastrointestinal problems which affect
- •absorption)
排除标准
- •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 , All participants at the Haga Teaching
- •Hospital are also eligible for the pharmacokinetic part of the study.
研究者
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