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

Inflammatix

Status: Enrolling

Conditions: Fever; Tachycardia; Infections; Sepsis

Treatments: Diagnostic Test: TriVerity Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT06637904

INF-29

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Pre-phase standard of care

No Intervention group

Description:

Participants in the pre-phase, treated with standard of care, will be gathered from a retrospective database using propensity matching.

Post-phase TriVerity Test

Experimental group

Description:

Participants in the post-phase will be managed incorporating the TriVerity Test results with standardized guidance for interpretation and resulting management actions.

Treatment:

Diagnostic Test: TriVerity Test