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
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Condition or disease |
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Sepsis |
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 |
- Accuracy of sequencing assay in diagnosing etiology of sepsis [ Time Frame: 7 days ]
Biospecimen Retention: Samples With DNA

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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 |
Inclusion Criteria:
- 18 years or older
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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.

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
United States, California | |
Stanford University Hospital | |
Stanford, California, United States, 94305 |
Principal Investigator: | Samuel Yang, MD | Stanford University |
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 |
Sepsis Toxemia Communicable Diseases Infections |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Disease Attributes |