NCT03868969Unknown2 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of patients with no signs of urinary tract infection
研究概览
简要总结
The aim of the study was to evaluate the clinical and microbiological efficacy of fosfomycin trometamol (FT) per os in the treatment of documented male urinary tract infections with ESBL-producing enterobacteriaceae
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Fosfomycin
Experimental
Fosomycin tromethamine, one sachet for 21 days
干预措施: Fosfomycin Oral Suspension (Drug)
结局指标
主要结局
Number of patients with no signs of urinary tract infection
时间窗: 28 days
Number of patients with no signs of urinary tract infection
次要结局
- Number of patients with digestive, cutaneous disturbance(28 days)
- Number of patients with persistence of clinical signs of urinary tract infection(3 days)
- Number of patients with reoccurrence of clinical signs of urinary tract infection and positive urinary analysis(3 months)
研究者
研究点 (1)
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