Actively Recruiting
TriVerity Test for Better Management of Emergency Department Patients With Suspected Infections, Fever, or Fast Heart Rate
Led by Inflammatix · Updated on 2025-01-08
300
Participants Needed
2
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the TriVerity™ Acute Infection and Sepsis Test to improve management of emergency department (ED) patients who have suspected infections along with rapid heart rate or fever. This study compares outcomes from a pre-phase where patients received standard care with a post-phase where the TriVerity Test results guide treatment choices. The goal is to see if incorporating this test improves compliance with sepsis treatment guidelines, patient disposition, appropriate use of antibiotics and antivirals, and health economic outcomes. Safety follow-up is included for patients in the post-phase to monitor any effects. During the post-phase, participants will have a 2.5 ml blood sample taken in the ED, processed using the TriVerity Cartridge on the Myrna Instrument. The test provides diagnostic information distinguishing bacterial, viral, or non-infectious inflammation and prognostic data on the need for intensive care. The pre-phase data comes from a retrospective database matched for comparison. Standardized guidance is used to interpret test results and direct clinical management in the post-phase. Participants will be assessed for sepsis treatment compliance within 72 hours of ED admission and monitored through to final disposition orders for up to 35 days. Researchers will track multiple outcomes including appropriate antimicrobial use and patient safety via follow-up calls. Participants need to be reachable by phone for safety checks, and various clinical and laboratory measurements will be collected to evaluate the test's impact on patient care and outcomes.
CONDITIONS
Official Title
TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Presenting to the emergency department with suspected acute infection (such as respiratory, urinary, abdominal, skin and soft-tissue infection, meningitis/encephalitis, or other infections)
- Having either a heart rate over 100 beats per minute or a temperature above 38°C
- Not immediately placed in a primary designated treatment room (e.g., waiting room, triage hallways, or ED staging/fast track area)
- Able to provide informed consent or have a legally authorized representative provide consent
- Reachable by confirmed working cell phone and willing to respond to follow-up safety checks
You will not qualify if you...
- Treatment with systemic antibiotics, antiviral, or antifungal agents within 7 days prior to ED presentation, except for chronic antiviral treatments (HIV, hepatitis B or C), topical agents, anti-herpes prophylaxis, or single-dose peri-operative antibiotics
- Receiving palliative, hospice, or limited interventional care
- Prisoners, mentally disabled, or unable to provide consent without a legally authorized representative
- Currently receiving experimental therapy or enrolled in an interventional clinical trial involving investigational drugs, devices, or vaccines
- Previously enrolled in this clinical trial
AI-Screening
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Trial Site Locations
Total: 2 locations
1
OSF HealthCare Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Actively Recruiting
2
Johns Hopkins Department of Emergency Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
S
Shailee Rasania
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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