Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-03-14 @ 11:14 AM
Study NCT ID:
NCT02127502
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2014-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VENUS: Septic Gene Expression Using SeptiCyte
Sponsor:
Immunexpress
Organization:
Study Overview
Official Title:
VENUS: Validation of Septic Gene ExpressioN Using SeptiCyte®
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VENUS
Brief Summary:
The investigators seek to evaluate a new test for determining presence of infection/sepsis as compared to non-infection/systemic inflammatory response syndrome among critically ill patients within the first 24 hours of their being hospitalized in an intensive care unit (ICU) within the first 7 days of hospitalization. The primary purpose of the study is to validate SeptiCyte® Lab in this population as compared to: 1) the doctor's impression and 2) existing clinical parameters. The investigators also hope to assess how well a related, new blood test, SeptID® identifies different types of infection, as compared to cultures and other lab tests.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: