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Next-Generation Sequencing Diagnostics of Bacteremia in Sepsis

NCT03356249 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2022-05-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Next-Generation Sequencing

In 500 patients with suspected or proven sepsis or septic shock (according to the Sepsis-3 definitions), patients´ characteristics and routine blood parameters will be determined at sepsis onset as well as 72 hours afterwards. At the same time points, 2 sets of blood cultures and one blood tube for Next-Generation Sequencing (NGS)-diagnostics will be collected. An evaluation of outcome will be performed at 28 days after sepsis onset.

Sponsors & Collaborators

  • Fraunhofer Institute for Interfacial Engineering and Biotechnology

    collaborator OTHER

  • Dietmar Hopp Stiftung GmbH

    collaborator UNKNOWN

  • University Hospital Heidelberg

    lead OTHER

Principal Investigators

  • Thorsten Brenner, MD · University Hospital, Essen

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-08-31
Completion
2021-09-30

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03356249 on ClinicalTrials.gov