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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date April 1, 2016
First Posted Date April 6, 2016
Last Update Posted Date October 27, 2017
Study Start Date April 2016
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2016)
Accuracy of sequencing assay in diagnosing etiology of sepsis [ Time Frame: 7 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SEP-SEQ Trial - Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay
Official Title SEP-SEQ Trial - Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Plasma
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
Condition Sepsis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 26, 2017)
350
Original Estimated Enrollment
 (submitted: April 1, 2016)
550
Actual Study Completion Date October 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02730468
Other Study ID Numbers 001-CL-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Karius, Inc.
Study Sponsor Karius, Inc.
Collaborators Stanford University
Investigators
Principal Investigator: Samuel Yang, MD Stanford University
PRS Account Karius, Inc.
Verification Date October 2017