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临床试验/DRKS00004678
DRKS00004678已完成不适用

Observational study to evaluate the microbiological efficacy of an antibiotic therapy with Nitroxolin (3 x 250 mg p.o.) in patients with lower urinary tract infection - NITRO_UTI

niversitätsklinikum JenaZentrum für Infektionsmedizin und Krankenhaushygiene0 个研究点目标入组 30 人开始时间: 2013年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
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
Observational

入排标准

年龄范围
60 Years 至 one(—)
性别
All

入选标准

  • (1) men and women aged at least 60 years and a therapy indication for Nitroxolin® according to the decision of the physician
  • (2) urine culture detecting at least one uropathogen with a bacterial count =10^5 cfu/ml
  • (3) at least one of the following symptoms of an urinary tract infection: dysuria, pollakisuria, intensified/new acquired urinary incontinence, odor/cloudy urine, intensified/new acquired physical weakness and abnormal fatigue, suprapubic pain
  • (4) written informed consent of the patient or its legal representative

排除标准

  • (1) sepsis defined as = 2 SIRS-criteria (body temperature less than 36°C or greater than 38°C, heart rate greater than 90 beats per minute, tachypnea (high respiratory rate), with greater than 20 breaths per minute, white blood cell count less than 4000 cells/µl or greater than 12 000 cells/µl)
  • (2) additional systemic antibiotic therapy (besides Nitroxolin®) within the last 48 h before day 1
  • (3) known renal insufficiency > stadium 3 (GFR <30ml/(min*m2))
  • (4) liver cirrhosis Child-Pugh Score B or C
  • (5) known allergy against Nitroxolin®

研究者

发起方
niversitätsklinikum JenaZentrum für Infektionsmedizin und Krankenhaushygiene

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