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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Sponsor:
Karius, Inc.
Collaborator:
Stanford University
Information provided by (Responsible Party):
Karius, Inc.
Tracking Information | ||||
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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 |
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 |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Plasma
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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. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
350 | |||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Responsible Party | Karius, Inc. | |||
Study Sponsor | Karius, Inc. | |||
Collaborators | Stanford University | |||
Investigators |
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PRS Account | Karius, Inc. | |||
Verification Date | October 2017 |