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

May 7, 2018 updated by: Karius, Inc.

Diagnosis of Bacteremia/Septicemia 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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who are at least 18 years of age, have been admitted to Duke University Hospital, and have a positive blood culture.

Description

Inclusion Criteria:

  1. 18 years or older
  2. A positive blood culture
  3. A suitable residual blood sample collected within 24 hours of the positive blood culture OR
  4. A blood sample obtained for the study obtain within 48 hours of the positive blood culture

For Endocarditis Cohort:

1. 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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Staphylococcus aureus Infection
Patients with blood culture confirmed S. aureus bloodstream infections.
Gram Negative Infection
Patients with blood culture confirmed Gram Negative bloodstream infecrions
Endocarditis
Patients admitted for evaluation of acute endocarditis classified using the Duke Criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karius, Inc.

Collaborators

Duke University

Investigators

  • Principal Investigator: Vance G Fowler, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

December 7, 2016

First Submitted That Met QC Criteria

December 7, 2016

First Posted (Estimate)

December 9, 2016

Study Record Updates

Last Update Posted (Actual)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 7, 2018

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 005-CL-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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