Recruiting

TriVerity™

Sponsor:

Inflammatix

Code:

NCT06637904

Conditions

Sepsis

Infections

Tachycardia

Fever

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TriVerity Test

Study Details

Brief 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.

Conditions

Sepsis

Infections

Tachycardia

Fever

Study ID

NCT06637904

Start date

Nov 8, 2024

Status verified date

Jan, 2025

Completion date

Mar 31, 2025

Anticipated

Primary completion date

Jan 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

  • SEP-1 bundle compliance [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Shailee Rasania

862-295-8740srasania@inflammatix.com

Locations

OSF HealthCare Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Dawn R Bolliger

815-848-2075dawn.r.bolliger@osfhealthcare.org

Abhigna C Madineni

309-624-2410abhigna.c.madineni@osfhealthcare.org

Johns Hopkins Department of Emergency Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Breana McBryde

443-812-8757bmcbryd1@jhmi.edu

Gaby Dashler

717-487-2060ggladfe1@jhmi.edu

More Information

Sponsor

Inflammatix

Last update posted

Jan 8, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Inflammatix on 2025-01-08.