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临床试验/NCT01138566
NCT01138566Unknown不适用

Clinical Significance and Optimal Treatment of Community-onset Urinary Tract Infections Caused by Extended-spectrum β-lactamase and/or AmpC β-lactamase Producing Enterobacteriaceae

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2010年6月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
400
试验地点
1

研究概览

简要总结

The purposes of this study are:

  1. To estimate the prevalence of extended spectrum β-lactamase (ESBL) and/or AmpC among Enterobacteriaceae which cause community-onset urinary tract infections (UTIs)
  2. To collect the background, risk factors and clinical outcome of patients with community-acquired uropathogenic condition related to Enterobacteriaceae (both ESBL, AmpC- and non ESBL and/or AmpC producing) after receive different antibiotic regimens.
  3. To develop a scoring system to early identify patients at risk of being infected with ESBL- and/or AmpC-producing Enterobacteriaceae by comparing the risk factors for community-onset UTIs caused by ESBL- and/or AmpC-positive against non ESBL -and/or AmpC Enterobacteriaceae
  4. To demonstrate the efficacy and safety of ertapenem for the empiric treatment of community-onset UTIs in patients at risk for ESBL- and/or AmpC-producing organism.

The study hypothesis (i) Patients infected with community-acquired uropathogenic ESBL- and/or AmpC-producing Enterobacteriaceae who receive regimens other than carbapenems have a worse outcome.

(ii) There are certain risk factors predicting the acquisition of community-onset UTIs caused by ESBL- and/or AmpC-producing Enterobacteriaceae.

(iii) The use of ertapenem is an effective and safe empirical therapy compared with other agents for community-onset UTIs caused by ESBL- and/or AmpC-producing Enterobacteriaceae.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients who admitted to the Taipei Veterans General Hospital with the diagnosis of community-onset UTI caused by Enterobacteriaceae will be eligible for inclusion in this study if hospitalization for parental antimicrobial therapy is required

排除标准

  • pregnancy or lactation in women,
  • history of serious allergy or intolerance to study drug therapy (patients with a history of mild rash to β-lactams could be enrolled),
  • complete obstruction of the urinary tract,
  • peri-nephritic or intrarenal abscess, prostatitis, any rapidly progressive disease or terminal illness,
  • immuno-compromising illness or immuno suppression therapy, the need for concomitant antimicrobials in addition to study therapy,
  • a baseline pathogen resistant to study drug,
  • treatment with a systemic antimicrobial agent for >24 h within 72 h prior to enrolment, or absolute neutrophil count <1000/mm
  • Men with a history or physical findings suggestive of acute or chronic prostatitis will also excluded.

研究者

申办方类型
Other Gov

研究点 (1)

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