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

• ClinicalTrials.gov Identifier: NCT02730468
• Recruitment Status: Completed
• First Posted: April 6, 2016
• Last Update Posted: October 27, 2017
• Sponsor: Karius, Inc.
• 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
• 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

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

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