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

Launched by INFLAMMATIX · Oct 9, 2024

Keywords

ClinConnect Summary

The TriVerity™ clinical trial is investigating a new test designed to improve the management of patients in the emergency department (ED) who may have infections. This study focuses on individuals who arrive at the ED with symptoms like a high heart rate or fever but are not immediately placed in a dedicated treatment room. Researchers want to see if using the TriVerity Test, which helps identify whether an infection is bacterial, viral, or due to other causes, can lead to better treatment decisions compared to the standard care that these patients currently receive.

To participate, you must be at least 18 years old and show signs of an acute infection along with a rapid heartbeat or fever. You also need to be someone who can give consent or have a representative who can do so for you. If you join the trial, you can expect to be monitored for your safety, and researchers will check in with you at specific times after your visit. This study aims to provide more effective treatment for patients with suspected infections, ultimately leading to improved outcomes and care in the emergency setting.

Gender

ALL

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.