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New treatment option for Sepsis
Official title TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections
ClinicalTrials.gov ID: NCT06637904
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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).
You likely can't join if
- Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to...
- Antiviral treatment for chronic viral infections, i.e., HIV, hepatitis B and hepatitis C
- Topical antibiotics, topical antivirals or topical antifungal agents
- Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
- Single dose of one or combination of peri-operative (prophylactic) antibiotics
- Patients receiving palliative or hospice care, or those receiving limited treatment care (see Appendix B).
See the full eligibility 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...
- 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).
- 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...
- Antiviral treatment for chronic viral infections, i.e., HIV, hepatitis B and hepatitis C
- Topical antibiotics, topical antivirals or topical antifungal agents
- Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
- Single dose of one or combination of peri-operative (prophylactic) antibiotics
- Patients receiving palliative or hospice care, or those receiving limited treatment 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 treatment clinical trial in which a subject receives some type of intervention, which can include but is not limited to investigational drugs...
- Participants previously enrolled in the present clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Peoria, Illinois, United States
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peoria, Illinois, United States; Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.