TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis

Completed

• Conditions: Respiratory Tract Infections; Urinary Tract Infections; Sepsis; Skin and Soft Tissue Infection; Suspected Meningitis/Encephalitis or Any Other Infection; Intra-Abdominal Infections

• Registration Number: NCT04094818
• Lead Sponsor: Inflammatix

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-17
• Study First Submitted QC: 2019-09-17
• Study First Posted: 2019-09-19
• Study Start: 2020-02-28
• Primary Completion: 2024-08-06
• Study Completion: 2024-09-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1441

Inclusion Criteria

1. Age >18 year

2. 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:

   • Heart rate: >90 beats/ minute
   • Temperature: >38 C or <36C
   • Respiratory Rate: >20 breaths / minutes or PaO2 of <60 mmHg or SpO2 <90%
   • Systolic blood pressure: <100 mmHg
   • Altered mental status: Per clinical exam

3. Able to provide informed consent, or consent by legally authorized representative.

Exclusion Criteria

Participants will be ineligible for this study if they meet any of the following criteria:

1. 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:

   1. Antiviral treatment for HIV infection and hepatitis B and hepatitis C
   2. Topical antibiotics, topical antiviral or topical antifungal agents
   3. Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
   4. Peri-operative (prophylactic) antibiotics
   5. 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

2. Patients receiving palliative or hospice care, or those receiving limited interventional care.

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. Patients 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.

   a. Subjects that are enrolled in non-interventional or observational clinical trials will be allowed to participate in this clinical trial.

5. Patients previously enrolled in the present clinical trial.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the diagnostic performance of HostDx Sepsis	28 Days After Enrollment	Concordance of HostDx Sepsis viral readout with clinical adjudication
Evaluation of the prognostic performance of HostDx Sepsis	7 Days After Enrollment	Concordance of HostDx Sepsis severity readout with receipt of ICU-level care (including requirement for ICU transfer, mechanical ventilation, vasopressors, or renal replacement therapy (RRT))

Secondary Outcome Measures

Name	Time	Method
Evaluation of the prognostic performance of HostDx Sepsis for 28-Day Hospital Mortality	28 Days after enrollment	Concordance of HostDx Sepsis severity readout with 28-Day Hospital Mortality
Evaluation of the prognostic performance of HostDx Sepsis	28 Days after enrollment	Concordance of HostDx Sepsis severity readout with receipt of ICU-level care (including requirement for ICU transfer, mechanical ventilation, vasopressors, or renal replacement therapy (RRT)) within 7 days OR 28-Day Hospital Mortality

Trial Locations

Locations (26)

University of South Alabama; 🇺🇸 Mobile, Alabama, United States

University of Southern California; 🇺🇸 Los Angeles, California, United States

University of California Davis Medical Center; 🇺🇸 Sacramento, California, United States

Medstar Health Research Institute; 🇺🇸 Washington, District of Columbia, United States

University of Florida (UF) - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Essentia Institute of Rural Health; 🇺🇸 Duluth, Minnesota, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Hackensack Meridian Health; 🇺🇸 Montclair, New Jersey, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Oklahoma University Health; 🇺🇸 Oklahoma City, Oklahoma, United States

Geisinger Health; 🇺🇸 Danville, Pennsylvania, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Texas Tech University Health Sciences Center - El Paso; 🇺🇸 El Paso, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

ATTIKON University Hospital; 🇬🇷 Athens, Greece