Phase
Condition
Urinary Tract Infections
Meningitis
Respiratory Syncytial Virus (Rsv) Infection
Treatment
TriVerity
HostDx Sepsis
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age >18 year
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
- 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:
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:
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 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
Patients receiving palliative or hospice care, or those receiving limitedinterventional care.
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.
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.
Patients previously enrolled in the present clinical trial.
Study Design
Connect with a study center
ATTIKON University Hospital
Athens,
GreeceSite Not Available
University of South Alabama
Mobile, Alabama 36617
United StatesSite Not Available
University of Southern California
Los Angeles, California 90033
United StatesSite Not Available
University of California Davis Medical Center
Sacramento, California 95817
United StatesSite Not Available
Medstar Health Research Institute
Washington, District of Columbia 20010
United StatesSite Not Available
University of Florida (UF) - Jacksonville
Jacksonville, Florida 32209
United StatesSite Not Available
Emory University
Atlanta, Georgia 30303
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52242
United StatesSite Not Available
University of Kentucky
Lexington, Kentucky 40536
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore, Maryland 21209
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Baystate Medical Center
Springfield, Massachusetts 01199
United StatesSite Not Available
Henry Ford Hospital
Detroit, Michigan 48202
United StatesSite Not Available
Essentia Institute of Rural Health
Duluth, Minnesota 55805
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
Hackensack Meridian Health
Montclair, New Jersey 07042
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
Oklahoma University Health
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Geisinger Health
Danville, Pennsylvania 17822
United StatesSite Not Available
University of Pittsburgh
Pittsburgh, Pennsylvania 15260
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Texas Tech University Health Sciences Center - El Paso
El Paso, Texas 79905
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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