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

Karius

Status: Completed

Conditions: Sepsis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02730468

001-CL-01

Details and patient eligibility

About

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.

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.