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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02730468
Other study ID # 001-CL-01
Secondary ID
Status Completed
Phase N/A
First received April 1, 2016
Last updated October 26, 2017
Start date April 2016
Est. completion date October 2017

Study information

Verified date October 2017
Source Karius, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date October 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Stanford University Hospital Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Karius, Inc. Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of sequencing assay in diagnosing etiology of sepsis 7 days
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