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

Part of paid clinical trials in Peoria, Illinois.

Sponsor
Inflammatix
Study ID
NCT06637904
Status
Recruiting
Apply to this trial

Conditions

  • Fever
  • Infections
  • Sepsis
  • Tachycardia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TriVerity Test — DIAGNOSTIC_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.

Study Details

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.

Key Dates

Start date
Nov 8, 2024
Status verified
Jan 2025
Primary completion
Jan 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

SEP-1 bundle compliance [ Time Frame: Within 72 hours of ED admission ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
OSF HealthCare Saint Francis Medical CenterPeoriaIllinois61637
Dawn R Bolliger
[email protected]
815-848-2075
Abhigna C Madineni
[email protected]
309-624-2410
Johns Hopkins Department of Emergency MedicineBaltimoreMaryland21287
Breana McBryde
[email protected]
443-812-8757
Gaby Dashler
[email protected]
717-487-2060

Find similar trials in Peoria, IL

By research site
OSF HealthCare Saint Francis Medical Center· Peoria, ILJohns Hopkins Department of Emergency Medicine· Baltimore, MD

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