Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637904
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
TriVerity for Improved Management of Emergency Department ED Patients With Suspected Infections
Sponsor:
None
Organization:
None
Study Overview
Official Title:
TriVerity for Improved Management of Emergency Department ED Patients With Suspected Infections
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIMED
Brief Summary:
A prepost interventional use trial with ED patients who are initially triaged to locations other than a dedicated patient room in the main ED eg waiting room hallway bed andor the staging areafast track area with suspected infection and tachycardia or fever will be enrolled Study conduct will be performed under an Investigational Device Exemption IDE from the Food and Drug Administration FDA Participants in the pre-phase treated with standard of care will be gathered from a retrospective database using propensity matching whereas participants in the post-phase will be managed incorporating the TriVerity Acute Infection and Sepsis Test results with standardized guidance for interpretation and resulting management actions Many outcomes will be captured and compared between the pre- and post-phase phases including sepsis bundle compliance patient disposition appropriate use of antimicrobials antibiotics and antivirals and health economic findings Safety measures for participants in the post-phase will include patient follow-up at predefined time points The objective is to demonstrate improvement of patient management when incorporating the TriVerity Test result compared to standard of care Improvements based on diagnostic bacterial vs viral vs non-infectious inflammation and prognostic need for 7-day ICU level care readouts of the TriVerity Test result will be tracked
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None