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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730468
• Other study ID #: 001-CL-01
• 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
• 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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Sepsis
• Toxemia

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