Next-Generation Sequencing Diagnostics of Bacteremia in Sepsis (NextGeneSiS)

NCT03356249 COMPLETED

Sepsis remains a major challenge, even in modern intensive care medicine. The identification of the causative pathogen is crucial for an early optimization of the antimicrobial treatment regime in patients with sepsis. In this context, culture-based diagnostic procedures (e.g. blood cultures) represent the standard of care, although they are associated with relevant limitations. Therefore, culture independent methods (e.g. Next-Generation Sequencing (NGS)) seem to be an attractive alternative. By the identification of circulating cell-free DNA in the blood and the use of the quantitative sepsis indicating quantifier (SIQ) score, causing pathogens can be identified and potential contaminations can be excluded. The goal of the presented study is therefore, to assess the diagnostic performance of a NGS-based approach for the detection of relevant infecting organisms in a big cohort of septic patients (n=500). Moreover, the plausibility of this NGS-based approach will be estimated by a panel of independent clinical specialists, retrospectively identifying potential changes in patients´ management based on NGS results.

Details

Lead sponsor	University Hospital Heidelberg
Status	COMPLETED
Enrolment	500
Start date	Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu Sep 30 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Sepsis
• Septic Shock

Interventions

• Next-Generation Sequencing

Countries

Germany