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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years

• Participant presents to ED with ALL of the below:

⁃ 1. Suspected acute infection (e.g., respiratory, urinary, abdominal, skin \& soft-tissue infection, meningitis/encephalitis, or any other infection), and 2.2. Either heart rate \>100 beats per minute or/and temperature \>38C. 2.3. NOT immediately roomed in a primary designated treatment location,( i.e., they can be in the waiting room, ED triage hallways, and/or ED staging area/fast track area).

• Able to provide informed consent, or consent by legally authorized representative.

• Reachable via confirmed working cell phone (with backup contact number) and willing to respond to follow-up safety checks (see below for details).

Locations
United States
Illinois
OSF HealthCare Saint Francis Medical Center
RECRUITING
Peoria
Maryland
Johns Hopkins Department of Emergency Medicine
RECRUITING
Baltimore
Contact Information
Primary
Shailee Rasania
srasania@inflammatix.com
862-295-8740
Time Frame
Start Date: 2024-11-08
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 300
Treatments
No_intervention: Pre-phase standard of care
Participants in the pre-phase, treated with standard of care, will be gathered from a retrospective database using propensity matching.
Experimental: Post-phase TriVerity Test
Participants in the post-phase will be managed incorporating the TriVerity Test results with standardized guidance for interpretation and resulting management actions.
Related Therapeutic Areas
Sponsors
Leads: Inflammatix

This content was sourced from clinicaltrials.gov