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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 TriVerityâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-phase standard of care | No Intervention | 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 | Participants in the post-phase will be managed incorporating the TriVerity Test results with standardized guidance for interpretation and resulting management actions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TriVerity Test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| SEP-1 bundle compliance | Mandatory hospital procedures for patients admitted with suspected sepsis | Within 72 hours of ED admission |
| Time to final ED disposition order | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients with antibiotics given in the ED combined with noninferior safety outcomes | 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 |
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Inclusion Criteria:
Age ≥18 years
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).
Able to provide informed consent, or consent by legally authorized representative.
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:
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:
Patients receiving palliative or hospice care, or those receiving limited interventional care (see Appendix B).
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.
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.
Participants previously enrolled in the present clinical trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shailee Rasania | Contact | 862-295-8740 | srasania@inflammatix.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OSF HealthCare Saint Francis Medical Center | Recruiting | Peoria | Illinois | 61637 | United States |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D013610 | Tachycardia |
| D005334 | Fever |
| ID | Term |
|---|---|
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Pre-phase is the control arm and Post-phase is the interventional arm (uses TriVerity Test intervention)
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Length of Stay |
| Date of enrollment (Day 0) to final Follow Up call (up to 35 days) |
| Diagnostic ordering practices | 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 | 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 | Overall hospital costs for patients that meet study criteria | Date of enrollment (Day 0) to 28 days |
| Johns Hopkins Department of Emergency Medicine | Recruiting | Baltimore | Maryland | 21287 | United States |
|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |