TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infectio… (NCT04094818) | Clinical Trial Compass
CompletedNot Applicable
TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis
United States, Greece1,441 participantsStarted 2020-02-28
Plain-language summary
This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin \& soft tissue infections; or suspected sepsis of any cause.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \>18 year
. Suspected acute infection (respiratory, urinary, abdominal, skin \& soft-tissue), and at least one of the symptoms OR, Suspected sepsis of any cause as defined by a blood culture order by the treating physician, and at least two of the symptoms:
. Able to provide informed consent, or consent by legally authorized representative.
Exclusion criteria
. Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to the emergency department study visit. Participants will not be excluded for use of:
. Antiviral treatment for HIV infection and hepatitis B and hepatitis C
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested something called HostDx Sepsis to help diagnose and predict outcomes for infections like the one I may have — is this type of diagnostic test available or being used at our hospital, and could it change how my infection is identified or managed?
2Since this trial is now completed, has my doctor seen any published results about how accurately HostDx Sepsis distinguished true sepsis from other infections, and do those findings affect how my case might be approached?
3The trial covered a wide range of infections — respiratory, urinary, skin, abdominal, and even meningitis — so given my specific type of suspected infection, would a tool like HostDx Sepsis be particularly relevant or less useful for my situation?
4Because this was a diagnostic and prognostic study rather than a treatment trial, what standard treatments are already available for my infection or suspected sepsis, and should we be focused on those first before considering any newer diagnostic approaches?
5If a test like HostDx Sepsis can predict how serious a sepsis case might become, is there any way my doctor could access similar prognostic tools now to help guide decisions about my care in the emergency setting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the diagnostic performance of HostDx Sepsis
Timeframe: 28 Days After Enrollment
2
Evaluation of the diagnostic performance of HostDx Sepsis
Timeframe: 28 Days After Enrollment
3
Evaluation of the prognostic performance of HostDx Sepsis
. Topical antibiotics, topical antiviral or topical antifungal agents
. Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
. Peri-operative (prophylactic) antibiotics
. A single dose of antimicrobials during the present ED visit (\<10h before blood draw); note single dose can be considered mono or combination therapy, wherein combination is administered as part of local Standard of Care and only one dose of each medication is administered within the allowable 10-hour window
. Patients receiving palliative or hospice care, or those receiving limited interventional care.
. 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.