ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

April 1, 2016
April 6, 2016
October 27, 2017
April 2016
September 2017   (Final data collection date for primary outcome measure)
Accuracy of sequencing assay in diagnosing etiology of sepsis [ Time Frame: 7 days ]
Same as current
Complete list of historical versions of study NCT02730468 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
SEP-SEQ Trial - Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay
SEP-SEQ Trial - Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Plasma
Probability Sample
Subjects will be at least 18 years of age and who present to the Emergency Department with the diagnosis of sepsis
Sepsis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
350
550
October 2017
September 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02730468
001-CL-01
No
Not Provided
Plan to Share IPD: Undecided
Karius, Inc.
Karius, Inc.
Stanford University
Principal Investigator: Samuel Yang, MD Stanford University
Karius, Inc.
October 2017