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

Last updated: January 6, 2025
Sponsor: Inflammatix
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Disease

Fever

Heart Disease

Treatment

TriVerity Test

Clinical Study ID

NCT06637904
INF-29
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years

  2. Participant presents to ED with ALL of the below:

2.1. 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. NOTimmediately roomed in a primary designated treatment location,( i.e., they can be inthe waiting room, ED triage hallways, and/or ED staging area/fast track area).

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

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

Exclusion

Exclusion Criteria:

  1. Patient-reported treatment with systemic antibiotics, systemic antiviral agents orsystemic antifungal agents within the past 7 days prior to presentation in thewaiting room of the ED. Participants will not be excluded for use of:

  2. Antiviral treatment for chronic viral infections, i.e., HIV, hepatitis B andhepatitis C

  3. Topical antibiotics, topical antivirals or topical antifungal agents

  4. Anti-herpes prophylaxis aiding suppression of a recuring herpes infection

  5. Single dose of one or combination of peri-operative (prophylactic) antibiotics

  6. Patients receiving palliative or hospice care, or those receiving limitedinterventional care (see Appendix B).

  7. Prisoners, mentally disabled, or unable to give consent. Should the patient not beable to provide informed consent the legally authorized representative can providethe consent on behalf of the patient.

  8. Participants receiving experimental therapy or already enrolled in an interventionalclinical trial in which a subject receives some type of intervention, which caninclude but is not limited to investigational drugs, medical devices, or vaccines.Participants that are enrolled in non-interventional or observational clinicaltrials will be allowed to participate in this clinical trial.

  9. Participants previously enrolled in the present clinical trial.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: TriVerity Test
Phase:
Study Start date:
November 08, 2024
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • OSF HealthCare Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Active - Recruiting

  • Johns Hopkins Department of Emergency Medicine

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

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