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.

Completed

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University Hospital

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Accuracy of sequencing assay in diagnosing etiology of sepsis

Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Karius, Inc.

Industry

Collaborators

Stanford University

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Apr 6, 2016
Registry last updated: Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed