NCT07303400进行中（未招募）不适用
Assessment of the Effectiveness of a Prototype Diagnostic System of Bacterial Respiratory Infections Based on Real-time Sequencing
Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月9日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- test positivity
研究概览
简要总结
The objective of this project is to test the efficiency of a novel developed protocol for direct real-time metagenomic sequencing of Lower Respiratory Infection samples. The investigators aim to assess the anticipation time, compared to the traditional culturing methods and the accuracy, compared to gold standards
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Willingness and ability to provide written informed consent prior to performing the study procedures
- •Patients older than 18 years of age
- •Suspected bacterial Lower Respiratory Infection (LRI)
- •500µL of lower respiratory tract sample (e.g. Bronchoalveolar lavage) are available after the routine diagnostic procedures are over
排除标准
- •Low amount of leftover specimen
- •Complex diagnosis: clinicians could require further analysis after the first diagnosis is produced
- •A sample of the same patient has been already included in the study
结局指标
主要结局
test positivity
时间窗: Baseline
assess the effectiveness in detection of positive (Gram+ vs Gram- vs mixed culture samples) vs negative samples
species identification
时间窗: Baseline
Assess the effectiveness in recognizing the correct bacterial species
次要结局
- anticipation time(Baseline)
研究者
Stefano Gaiarsa
Researcher
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (1)
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