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

Completed

• Conditions: Sepsis

• Registration Number: NCT02730468
• Lead Sponsor: Karius, Inc.

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 available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-04-01
• Study First Posted: 2016-04-06
• Primary Completion: 2017-09
• Status Verified: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of sequencing assay in diagnosing etiology of sepsis	7 days

Trial Locations

Locations (1)

Stanford University Hospital; 🇺🇸 Stanford, California, United States