NANO-RAST: Nanomotion-based Resistell AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia and/or Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Sensitivity of Resistell AST
研究概览
简要总结
Blood culture samples from bacteremia patients positive for Gram-negative bacteria will be tested for antibacterial susceptibility using Resistell Phenotech device. The results will be compared with current AST gold standard tests to calculate sensitivity, specificity, and accuracy of Resistell Phenotech device.
详细描述
NANO-RAST: Nano-motion based Resistell AST to determine the antibiotic susceptibility of bacteria causing bacteremia and sepsis.
Study population: patients admitted at the study site with bacteremia considered to be due to a pathogenic strain (E. coli or K. pneumoniae).
Study design: prospective, observational, single arm study.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •The patients meeting all the following criteria can be recruited in the study:
- •patients over the age of 18 years who sign, or their relatives / legal representatives sign the informed consent form;
- •patients with bacteremia considered to be due to a pathogenic strain;
- •patients hospitalized at CHUV at the time of blood culture inoculation;
- •patients whose positive blood cultures were not older than 24 hours at the time of AST start.
- •Exclusion Criteria The patients meeting any of the following criteria will be excluded from the study:
- •patient is diagnosed with polymicrobial bacteremia;
- •samples can be excluded from the study during the processing of samples in case of technical errors e.g. failure with attachment of cells, technical problem with the device or sensor, operator's error, etc.
- •Note: in the event that the capacity of the Resistell instruments is reached for the day, no more ICFs will be obtained for the day.
排除标准
- 未提供
结局指标
主要结局
Sensitivity of Resistell AST
时间窗: Approximately 30 months
The primary endpoint will be the sensitivity of the device in detecting antibiotic susceptibility in blood samples positive for Gram-negative bacteria.
次要结局
- Accuracy and Specificity of Resistell AST(Approximately 30 months)
- Time to Result (TTR)(Approximately 30 months)