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临床试验/NCT04577989
NCT04577989已完成不适用

Clinical Comparison of Treatment Strategies in AmpC Beta-lactamase Producing Enterobacterales in a Swiss Tertiary Care Hospital (AmpC-strat Basel)

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2020年12月14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
270
试验地点
1
主要终点
descriptive analyses of demographic data in patients with detection of AmpC beta-lactamase producing Enterobacterales

研究概览

简要总结

This study is to investigate the recent epidemiological trends and the treatment outcome in terms of the length of hospital stay, the relevant renal and neurological side effects, risk factors for developing these side effects, the selection of more resistant pathogens under therapy as well as the incidence of Clostridium difficile infections under treatment.

详细描述

Increasing resistance among Enterobacterales to beta-lactam antibiotics is globally a major concern in the antibiotic resistance crisis. In gram-negative bacteria it evolves primarily through the production of beta-lactamases that allow the rapid hydrolysis of common antibiotics - most notably 3rd generation cephalosporins. Particularly, the production of Ambler class C beta-lactamase (AmpC) is a very concerning and unique resistance mechanism as so called derepressed mutants can be induced during treatment. Information on recent epidemiological trends as well as comparative information about the treatment strategies (cefepime versus piperacillin/tazobactam versus carbapenems) for infections with AmpC-producing Enterobacterales in Switzerland is still lacking. This study is to investigate the recent epidemiological trends and the treatment outcome in terms of the length of hospital stay, the relevant renal and neurological side effects, risk factors for developing these side effects, the selection of more resistant pathogens under therapy as well as the incidence of Clostridium difficile infections under treatment.

研究设计

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

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

  • Patients with detection of AmpC beta-lactamase producing Enterobacterales
  • In a blood culture (any ward)
  • In a clinical sample of the lower respiratory tract (only intensive care unit)

排除标准

  • Patients with documented refusal of subsequent use of their data

结局指标

主要结局

descriptive analyses of demographic data in patients with detection of AmpC beta-lactamase producing Enterobacterales

时间窗: single time-point at baseline

collection of demographic data (age, gender, hospital admission and discharge date, length of stay, ICU-stay, hospitalization prior to current hospital stay, discharge destination, outcome, cause of death, travel); descriptive analyses summarized as counts

descriptive analyses of microbiological data in patients with detection of AmpC beta-lactamase producing Enterobacterales

时间窗: single time-point at baseline

descriptive analyses of microbiological data Species of AmpC producing Enterobacterales, type of sample, date of sample, history of colonization or infection with any antibiotic resistant pathogen, Gram-staining of endotracheal aspirate or bronchoalveolar lavage (BAL), neutrophile and epitheliale cell count, results of culture from sputum, endotracheal aspirate, BAL or lung tissue) summarized as counts

descriptive analyses of treatment data in patients with detection of AmpC beta-lactamase producing Enterobacterales

时间窗: single time-point at baseline

descriptive and comparative analyses of treatment data (empiric and definitive antibiotic therapy including dosage, date of initiation/ discontinuation and changes in antibiotic therapy, exposures to other antimicrobials, concomitant medication, side effects) summarized as counts

descriptive analyses of clinical data in patients with detection of AmpC beta-lactamase producing Enterobacterales

时间窗: single time-point at baseline

descriptive analyses of clinical data (comorbidities, renal function, previous exposure to antibiotics and proton pump inhibitors, immunosuppressive treatment, date of diagnosis and type of infection with AmpC producing Enterobacterales) summarized as counts

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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