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 States1,441 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 range18 Years
SexALL
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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
✕. 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.
✕
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
. 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.