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TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis | Clinical Trials | Clareo Health

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

NCT04094818•Inflammatix

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

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 D.C., 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

Key Dates

Start Date

February 28, 2020

Primary Completion Date

August 6, 2024

Completion Date

September 30, 2024

Last Updated

October 22, 2024

Enrollment

1,441

ACTUAL participants

Conditions

Respiratory Tract InfectionsUrinary Tract InfectionsIntra-Abdominal InfectionsSkin and Soft Tissue InfectionSuspected Meningitis/Encephalitis or Any Other InfectionSepsis

Interventions

TriVerity

DIAGNOSTIC_TEST

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

NCT05488340

Urinary Tract Infections

View study

RECRUITING

The Fever Clinic Acute Respiratory Cohort

NCT07278700

Acute Respiratory InfectionsFebrile Illnesses+3 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

The Fever Clinic Acute Respiratory Cohort

Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections

Respiratory Infections in Young Children

Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children