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SEP-SEQ Trial - Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay

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ClinicalTrials.gov Identifier: NCT02730468
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Karius, Inc.

Study Description
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Brief Summary:
The purpose of this study is to evaluate the performance of the Karius Infectious Diseases Plasma Sequencing Assay in patients who present to the emergency room with sepsis.

Condition or disease
Sepsis

Study Design
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Study Type : Observational
Actual Enrollment : 350 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: SEP-SEQ Trial - Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay
Study Start Date : April 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of sequencing assay in diagnosing etiology of sepsis [ Time Frame: 7 days ]

Biospecimen Retention:   Samples With DNA
Plasma

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects will be at least 18 years of age and who present to the Emergency Department with the diagnosis of sepsis
Criteria

Inclusion Criteria:

  1. 18 years or older

  2. Meet 2 of 4 sepsis criteria

    1. Temperature > 38C or < 36C
    2. Heart rate > 90 bpm
    3. Respiratory rate >20 or PaCO2 <32mmHg
    4. WBC >12000/µL or < 4000/µL or > 10% bands

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02730468


Locations
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United States, California
Stanford University Hospital
Stanford, California, United States, 94305
Sponsors and Collaborators
Karius, Inc.
Stanford University
Investigators
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Principal Investigator: Samuel Yang, MD Stanford University
More Information
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Responsible Party: Karius, Inc.
ClinicalTrials.gov Identifier: NCT02730468    
Other Study ID Numbers: 001-CL-01
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Sepsis
Toxemia
Communicable Diseases
Infections
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes