跳至主要内容
临床试验/NCT06624618
NCT06624618招募中不适用

Rapid Molecular Detection of Sepsis in Whole Blood

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Development and validation of rapid diagnostics tests for detection of bacterial DNA in sepsis

研究概览

简要总结

Rapid diagnosis of sepsis is crucial for treatment and survival. Currently, blood culture takes 48 hours-5 days to complete. After starting antimicrobial treatment blood culture results are not reliable. As a result, empirical broad spectrum antimicrobial therapy is mostly used. This implies possible antimicrobial over- or under treatment which is associated with increased antimicrobial resistance development. Early identification of the causative pathogen of sepsis will therefore have a major impact on the adequate treatment and reduction of high mortality rates. To date, there is not a single molecular diagnostic test available on the market to detect all putative causative bacterial pathogens of sepsis. In this study, the investigators will develop and validate a completely new molecular sepsis approach based on pathogen DNA detection, as an alternative to culture.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are included when routine blood cultures are ordered for diagnosis of bloodstream infections.

排除标准

  • 未提供

结局指标

主要结局

Development and validation of rapid diagnostics tests for detection of bacterial DNA in sepsis

时间窗: 2 years

The tests will report presence of bacterial DNA by giving a specific bacterial species name.

Patterns of bacterial DNA dynamics over time

时间窗: 2 years

Use of species-specific qPCR primers (either from existing sepsis literature or to be designed) to quantify the DNA load at at least 3 different time points during an infectious episode. Comparison of these loads with infectious parameters used for routine diagnostics and with antibiotic use.

次要结局

  • Distinguishing between the causative pathogen and contamination by a physician evaluation panel, both for the current gold standard (blood cultures) and the results of new microbiological tests for detecting sepsis pathogens(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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