NCT02730468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

April 1, 2016

Last Update Submit

October 26, 2017

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Accuracy of sequencing assay in diagnosing etiology of sepsis

    7 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects will be at least 18 years of age and who present to the Emergency Department with the diagnosis of sepsis

You may qualify if:

  • years or older
  • Meet 2 of 4 sepsis criteria
  • Temperature \> 38C or \< 36C
  • Heart rate \> 90 bpm
  • Respiratory rate \>20 or PaCO2 \<32mmHg
  • WBC \>12000/µL or \< 4000/µL or \> 10% bands

You may not qualify if:

  • Inability to understand instructions and comply with study-related procedures
  • Any condition that in the opinion of the treating physician will prevent the subject from completing the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Hospital

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Samuel Yang, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2016

First Posted

April 6, 2016

Study Start

April 1, 2016

Primary Completion

September 1, 2017

Study Completion

October 1, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations

US(1)