Clinical trial NCT06637904: TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections
Official title: TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sepsis
Infections
Tachycardia
Fever
Lead sponsor: Inflammatix
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pre-phase is the control arm and Post-phase is the interventional arm (uses TriVerity Test intervention)
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: SEP-1 bundle compliance
timeFrame: Within 72 hours of ED admission
measure: Time to final ED disposition order
timeFrame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
Secondary outcomes:
measure: Percent of patients with antibiotics given in the ED combined with noninferior safety outcomes
timeFrame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
measure: Emergency Department LOS
timeFrame: Date of enrollment (Day 0) to final Follow Up call (up to 35 days)
measure: Diagnostic ordering practices
timeFrame: Date of enrollment (Day 0) to 72 hours
measure: Hospital admission rates
timeFrame: Date of enrollment (Day 0) to 72 hours
measure: Total hospital costs
timeFrame: Date of enrollment (Day 0) to 28 days
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF HealthCare Saint Francis Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Department of Emergency Medicine
state: Maryland
Study officials:
References: