Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Real Time PCR-ARES PCR 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
- PCR results
研究概览
简要总结
Experimental study without drug and device, on pseudo-anonymized samples archived at the Tropica Biobank.
The objective is to evaluate the performance for the identification of microorganisms in blood samples and rectal swabs of real time PCR assays for the targets: KPC, VIM, IMP, NDM, Acinetobacter OXA, Oxa48, MCR.
The evaluations will be carried out taking into consideration the data obtained from the diagnostic routine at the DITM.
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 at the Tropica Biobank has been signed
排除标准
- •Absence of data relating to positivity or negativity to the germs of interest
- •Absence of stored residual material
- •Absence of information and consent to the conservation of biological samples for signed research purposes
研究组 & 干预措施
Biological samples
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.
干预措施: ARES PCR (Diagnostic Test)
结局指标
主要结局
PCR results
时间窗: Baseline
Results (positive/negative and microorganism identification) obtained by real time PCR.
次要结局
- Gene mutations(Baseline)