Resistell Phenotech AST to Determine the Antibiotic Susceptibility of Gram-negative Bacteria Causing Bacteremia: a Prospective, Non-interventional, Multi-centric, Clinical Performance Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 246
- 试验地点
- 3
- 主要终点
- Sensitivity of the Resistell Phenotech vs Kirby-Bauer
研究概览
简要总结
The aim of this study is to assess the sensitivity, specificity, and accuracy of the Resistell Phenotech device in testing antibiotic susceptibility of Gram-negative bacteria (i.e., E. coli or K. pneumoniae) to clinically relevant antibiotics. The study is designed as a prospective, non-interventional, multi-center, single-arm study.
The blood culture samples from bacteremia patients that are positive for E. coli or K. pneumoniae will be tested with the Resistell Phenotech device after strain identification by MALDI-TOF. The results of the Resistell AST will be compared with the results from the disk diffusion tests (all sites use the Kirby-Bauer disk diffusion test), and site dependent tests (VITEK® 2, BD Phoenix™, MicroScan WalkAway system, and/or EUCAST RAST), which are currently the standard AST methods in the microbiology laboratories at the participating sites.
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
- •Patients who have signed a General Consent form approving use of their residual blood samples for research purposes (applicable at CHUV only)
- •Patients who have signed a consent allowing the use of their residual sample (Restprobenerklärung) (applicable at MUI, only)
- •Patients over the age of 18 years (>18)
- •Patients with bacteremia considered to be due to E. coli or K. pneumoniae
- •Patients whose positive blood cultures were not older than 24 hours at the time of AST start
排除标准
- •Patients with documented refusal of the use of biological material for research purposes (applicable at CHUV, only)
- •Patients with polymicrobial bacteremia
结局指标
主要结局
Sensitivity of the Resistell Phenotech vs Kirby-Bauer
时间窗: 18 months
To assess the sensitivity of the Resistell Phenotech in detecting antibiotic susceptible bacteria in blood samples positive for E. coli or K. pneumoniae, compared to the gold standard Kirby-Bauer disk diffusion test.
次要结局
- Sensitivity, specificity, and accuracy of the Resistell Phenotech vs other comparators(18 months)
- Time to result of Resistell Phenotech vs Kirby-Bauer and other comparators(18 months)
- Specificity and accuracy of the Resistell Phenotech vs Kirby-Bauer(18 months)
- Category agreement and discrepancies(18 months)