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
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:
- To estimate the prevalence of extended spectrum β-lactamase (ESBL) and/or AmpC among Enterobacteriaceae which cause community-onset urinary tract infections (UTIs)
- 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.
- 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
- 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
- 否
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
研究点 (1)
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