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

January 6, 2025 updated by: Inflammatix
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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. 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).

  3. Able to provide informed consent, or consent by legally authorized representative.
  4. Reachable via confirmed working cell phone (with backup contact number) and willing to respond to follow-up safety checks (see below for details).

Exclusion Criteria:

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

    1. Antiviral treatment for chronic viral infections, i.e., HIV, hepatitis B and hepatitis C
    2. Topical antibiotics, topical antivirals or topical antifungal agents
    3. Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
    4. Single dose of one or combination of peri-operative (prophylactic) antibiotics
  2. Patients receiving palliative or hospice care, or those receiving limited interventional care (see Appendix B).
  3. Prisoners, mentally disabled, or unable to give consent. Should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient.
  4. Participants receiving experimental therapy or already enrolled in an interventional clinical trial in which a subject receives some type of intervention, which can include but is not limited to investigational drugs, medical devices, or vaccines. Participants that are enrolled in non-interventional or observational clinical trials will be allowed to participate in this clinical trial.
  5. Participants previously enrolled in the present clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SEP-1 bundle compliance
Time Frame: Within 72 hours of ED admission
Mandatory hospital procedures for patients admitted with suspected sepsis
Within 72 hours of ED admission
Time to final ED disposition order
Time Frame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Time from Triage (on Day 0) to the Time the ED physician orders the subject disposition (i.e., where the subject will go next: admittance or discharge).
Date of enrollment (Day 0) to final Follow Up call (up to 35 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of patients with antibiotics given in the ED combined with noninferior safety outcomes
Time Frame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Calculated based on number of patients given antibiotics in ED
Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Emergency Department LOS
Time Frame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Length of Stay
Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Diagnostic ordering practices
Time Frame: Date of enrollment (Day 0) to 72 hours
Capturing the diagnostic ordering practices of attending physician (comparing physician choices and decisions before and after the TriVerity Test)
Date of enrollment (Day 0) to 72 hours
Hospital admission rates
Time Frame: Date of enrollment (Day 0) to 72 hours
Overall admission rates for patients that meet study criteria from emergency department to other location (e.g., ICU)
Date of enrollment (Day 0) to 72 hours
Total hospital costs
Time Frame: Date of enrollment (Day 0) to 28 days
Overall hospital costs for patients that meet study criteria
Date of enrollment (Day 0) to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inflammatix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 8, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

September 5, 2024

First Submitted That Met QC Criteria

October 9, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INF-29

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infections

Clinical Trials on TriVerity Test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe