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

Last updated: October 18, 2024
Sponsor: Inflammatix
Overall Status: Completed

Phase

N/A

Condition

Urinary Tract Infections

Meningitis

Respiratory Syncytial Virus (Rsv) Infection

Treatment

TriVerity

HostDx Sepsis

Clinical Study ID

NCT04094818
INF-04
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age >18 year

  2. Suspected acute infection (respiratory, urinary, abdominal, skin & soft-tissue), andat least one of the symptoms OR, Suspected sepsis of any cause as defined by a bloodculture 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

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

Exclusion

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 orsystemic antifungal agents within the past 7 days prior to the emergency departmentstudy visit. Participants will not be excluded for use of:

  2. Antiviral treatment for HIV infection and hepatitis B and hepatitis C

  3. Topical antibiotics, topical antiviral or topical antifungal agents

  4. Anti-herpes prophylaxis aiding suppression of a recuring herpes infection

  5. Peri-operative (prophylactic) antibiotics

  6. A single dose of antimicrobials during the present ED visit (<10h before blooddraw); note single dose can be considered mono or combination therapy, whereincombination is administered as part of local Standard of Care and only one doseof each medication is administered within the allowable 10-hour window

  7. Patients receiving palliative or hospice care, or those receiving limitedinterventional care.

  8. Prisoners, mentally disabled, or unable to give consent. Should the patient not beable to provide informed consent the legally authorized representative can providethe consent on behalf of the patient.

  9. Patients receiving experimental therapy or already enrolled in an interventionalclinical trial in which a subject receives some type of intervention, which caninclude but is not limited to investigational drugs, medical devices, or vaccines. a. Subjects that are enrolled in non-interventional or observational clinical trialswill be allowed to participate in this clinical trial.

  10. Patients previously enrolled in the present clinical trial.

Study Design

Total Participants: 1441
Treatment Group(s): 2
Primary Treatment: TriVerity
Phase:
Study Start date:
February 28, 2020
Estimated Completion Date:
September 30, 2024

Connect with a study center

  • ATTIKON University Hospital

    Athens,
    Greece

    Site Not Available

  • University of South Alabama

    Mobile, Alabama 36617
    United States

    Site Not Available

  • University of Southern California

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Medstar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • University of Florida (UF) - Jacksonville

    Jacksonville, Florida 32209
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • Johns Hopkins Hospital

    Baltimore, Maryland 21209
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Baystate Medical Center

    Springfield, Massachusetts 01199
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Essentia Institute of Rural Health

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Hackensack Meridian Health

    Montclair, New Jersey 07042
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • Oklahoma University Health

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Geisinger Health

    Danville, Pennsylvania 17822
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15260
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Texas Tech University Health Sciences Center - El Paso

    El Paso, Texas 79905
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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