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

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	Complete list of historical versions of study NCT02730468 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other 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: 18 years or older; Meet 2 of 4 sepsis criteria Temperature > 38C or < 36C Heart rate > 90 bpm Respiratory rate >20 or PaCO2 <32mmHg WBC >12000/µL or < 4000/µL or > 10% bands 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.
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