NCT01700842已完成不适用
Multicenter Study of Antimicrobial Resistance of Gram-positive and Gram-negative Clinical Strains to Ceftaroline and Other Antimicrobials in Russia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Percentage(numerical) MIC distribution of microorganisms for ceftaroline and other tested antimicrobials, including MIC50 and MIC90, percent(quantity)of susceptible and resistant strains in accordance with EUCAST or CLSI recommended breakpoints.
研究概览
简要总结
Approximately 3,000 of clinically significant isolates of different species from respective respective sources in geographically distinct Russian cities will be collected and tested on ceftaroline and other antimicrobials.
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Isolates derived from patients' clinical material will be included in the study
- •Isolates collected retro- and prospectively will be included in the study (from 01.01.2008 till 31.12.2012)
- •Isolates, allocated of a clinical material of adult patients (> 18 years), should make not less than 70 % from total number of included isolates)
- •All included isolates should be unique: only one isolate can be included in the study of each biological type from each patient
- •All isolates should correspond to clinic-laboratory criteria of the etiologic importance, i.e. should be derived from patients with infection symptoms from the corresponding clinical material
- •Case report form (CRF) (Appendix 1) should be correctly completed for each isolate
排除标准
- •ESBL-producing representatives of Enterobacteriaceae (ESBL-Extended-spectrum beta-lactamase)
- •Isolates, arrived in the central laboratory contaminated or unviable
结局指标
主要结局
Percentage(numerical) MIC distribution of microorganisms for ceftaroline and other tested antimicrobials, including MIC50 and MIC90, percent(quantity)of susceptible and resistant strains in accordance with EUCAST or CLSI recommended breakpoints.
时间窗: up to 3 months
MIC- Minimum inhibitory concentration; EUCAST - European Committee on Antimicrobial Susceptibility Testing; CLSI- Clinical and Laboratory Standard Institute
次要结局
- Percentage(numerical)MIC distribution of microorganisms,including MIC50 and MIC90, percent(quantity) of susceptible and resistant strains, to tested antibiotics depend on: infection localization, medical condition, ward/unit profile,patient profile(age)(up to 3 months)
- Percentage(numerical)MIC distribution of microorganisms,including MIC50 and MIC90, percent(quantity) of susceptible and resistant strains,to ceftaroline and other antimicrobials by years from 2008 to 2012(upto 3 months)
研究者
研究点 (1)
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