Skip to main content
OpenTrials
Completed

NCT Number: NCT02988414

Diagnosis of Bacteremia/Septicemia and Culture Negative Endocarditis by the Karius Sequencing-Based Infectious Disease Diagnostic Assay

Prospective study at Duke University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to blood culture results in admitted patients with bacteremia/septicemia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septicemia Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • A positive blood culture
  • A suitable residual blood sample collected within 24 hours of the positive blood culture OR
  • A blood sample obtained for the study obtain within 48 hours of the positive blood culture

For Endocarditis Cohort:

  • All criteria above must be met and patient is admitted to the hospital and evaluated for acute endocarditis classified per the Duke Criteria

Exclusion criteria

  • Inability to understand instructions and comply with study-related procedures
  • Any condition that in the opinion of the treating physician will prevent the subject from completing the study

Treatment and study plan

Primary outcomes

  1. Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius test compared with blood culture in patients with bacteremia/septicemia

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Karius, Inc.

Industry

Collaborators

  • Duke University

Registry information

Official study title

Diagnosis of Bacteremia/Septicemia by the Karius Sequencing-Based Infectious Disease Diagnostic Assay

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 9, 2016
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.