Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Microorganism presence (positive/negative)
研究概览
简要总结
This is an experimental study without drug and device, non-profit, on biological samples stored at the Tropica Biobank of the DITM. The aim of the project is to verify the performance of NGS-based assays, which can be used in the field of microbiology. The clinical evaluation investigations of NGS technology will be conducted on an adequate number of clinical blood samples and rectal swabs. The analyzes will be compared with the standard microbiology methods used in the DITM diagnostic routine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Samples of patients for whom blood culture and Multi Drug Resistant (MDR) surveillance tests were carried out in rectal swabs at the IRCCS Sacro Cuore Don Calabria Hospital
- •Samples for which the Information and consent to the conservation of biological samples for research purposes has been signed at the Tropica Biobank or
- •Samples for which, after all reasonable efforts, it was not possible to obtain the signature of the Information and consent to the conservation of biological samples for research purposes at the Tropica Biobank (e.g. patients in intensive care, immobilized patients unable to sign or with serious alterations of consciousness).
排除标准
- •Absence of data relating to positivity or negativity to the germs of interest
- •Absence of stored residual material
研究组 & 干预措施
NGS analysis
Residual anonymized samples stored at -80°C at the Tropica Biobank of the DITM and for which diagnostic analysis for germ infection has previously been carried out at the DITM by blood culture and MDR surveillance in routine diagnostic rectal swab will be used. DNA extraction will be carried out on these residual samples (with subsequent quality and quantification analysis of the nucleic acid) for subsequent NGS analyses.
干预措施: NGS Analysis (Diagnostic Test)
结局指标
主要结局
Microorganism presence (positive/negative)
时间窗: Baseline
Microorganism presence identified by NGS technology.
Microorganism identification
时间窗: Baseline
Microorganism identification obtained using NGS technology.
次要结局
- Identification of Gene mutations that convey resistance to antibiotics (resistant/susceptible)(Baseline)