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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02730468

Enrollment

350

Registered

2016-04-06

Start date

2016-04-30

Completion date

2017-10-31

Last updated

2017-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Accuracy of sequencing assay in diagnosing etiology of sepsis	7 days

Countries

United States

Outcome results