NCT06637904

TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Inflammatix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A pre/post interventional use trial, with ED patients who are initially triaged to locations other than a dedicated patient room in the main ED (e.g., waiting room, hallway bed, and/or the staging area/fast 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.

Conditions

• Sepsis
• Infections
• Tachycardia
• Fever

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	TriVerity Test	Participants in the post-phase of the study will have a 2.5 ml whole blood draw obtained via venipuncture into a PAXgene® Blood RNA tube. Blood samples will be processed using the TriVerity Cartridge on the Myrna Instrument located in the ED.

Timeline

• Start date: 2024-11-08
• Primary completion: 2025-01-31
• Completion: 2025-03-31
• First posted: 2024-10-15
• Last updated: 2025-01-08

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study