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HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis (SEPSIS-SHIELD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04094818
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Respiratory Tract Infections Urinary Tract Infections Intra-Abdominal Infections Skin and Soft Tissue Infection Sepsis Diagnostic Test: HostDx Sepsis

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: HostDx Sepsis in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis
Actual Study Start Date : February 28, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis


Intervention Details:
  • Diagnostic Test: HostDx Sepsis
    Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection


Primary Outcome Measures :
  1. Concordance of HostDx Sepsis diagnostic test read-out: likelihood of bacterial infection [ Time Frame: 28 Days After Enrollment ]
    Percent agreement of HostDx Sepsis bacterial readout with clinical adjudication by physician 28 days after enrollment for the presence of a bacterial infection

  2. Concordance of HostDx Sepsis diagnostic test read-out: likelihood of viral infection [ Time Frame: 28 Days After Enrollment ]
    Percent agreement of HostDx Sepsis viral readout with clinical adjudication by physician 28 days after enrollment for the presence of a viral infection

  3. Evaluation of the prognostic performance of HostDx Sepsis [ Time Frame: 7 Days After Enrollment ]
    Receipt of ICU-level care (including requirement for ICU transfer, mechanical ventilation, vasopressors, or renal replacement therapy (RRT))


Secondary Outcome Measures :
  1. Evaluation of the prognostic performance of HostDx Sepsis using number of participants requiring ICU level care [ Time Frame: 5 Days ]
    Composite receipt of ICU-level care (including requirement for ICU transfer, mechanical ventilation, vasopressors, or renal replacement therapy (RRT)

  2. Evaluation of the prognostic performance of HostDx Sepsis using a composite endpoint of number of participants Hospital Mortality [ Time Frame: 28 Days ]
    28-Day Hospital Mortality


Biospecimen Retention:   Samples Without DNA
PAXgene RNA tubes containing whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting to the emergency departments of enrolling sites with:

  1. Suspected infection and one or more abnormal vital signs, OR
  2. Patients with suspected sepsis of any cause as defined by a blood culture order by the treating physician and two or more abnormal vital signs
Criteria

Inclusion Criteria:

  1. Age >18 year
  2. Suspected 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:

  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 the following:

    • Use of topical antibiotics, topical antiviral or topical antifungal agents
    • Use of peri-operative (prophylactic) antibiotics
    • Use of a single dose of antibiotics during the present ED visit (<6h before blood draw).
  2. 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.
  3. Previously enrolled in the present clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04094818


Contacts
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Contact: Oliver Liesenfeld, MD (650) 443-3030 clinicaltrials@inflammatix.com

Locations
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United States, California
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Larissa May       LSMay@UCDavis.edu   
United States, District of Columbia
Medstar Health Research Institute Recruiting
Washington, District of Columbia, United States, 20010
Contact: Theresa Moriarty       Theresa.M.Moriarty@medstar.net   
United States, Florida
University of Florida (UF) - Jacksonville Recruiting
Jacksonville, Florida, United States, 32209
Contact: Morgan Henson       Morgan.Henson@jax.ufl.edu   
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Cathy Fairfield    319-384-8335    catherine-fairfield@uiowa.edu   
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Theresa Mims    859-218-5540    theresa.mims@uky.edu   
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Cynthia Kardos       cynthia.kardos@baystatehealth.org   
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Jasreen Kaur Gill    313-694-6063    jgill2@hfhs.org   
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer Quam    507-293-3596    quam.jennifer@mayo.edu   
United States, New Jersey
Hackensack Meridian Health Recruiting
Montclair, New Jersey, United States, 07042
Contact: Diana Caufield    732-776-3476    diana.caufield@hackensackmeridian.org   
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Stephanie Stoianoff    216-444-0231    StoianS@ccf.org   
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Kaleigh Doherty       dohertyk@upmc.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Christina Kampe       christina.kampe@vumc.org   
United States, Texas
Texas Tech University Health Sciences Center - El Paso Recruiting
El Paso, Texas, United States, 79905
Contact: Danielle Austin    915-215-4648    Danielle.Austin@ttuhsc.edu   
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Matthew Faron    414-805-6967    mfaron@mcw.edu   
Sponsors and Collaborators
Inflammatix
Publications:

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Responsible Party: Inflammatix
ClinicalTrials.gov Identifier: NCT04094818    
Other Study ID Numbers: INF-04
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inflammatix:
Infection
mRNA
Procalcitonin
C-Reactive Protein
Lactate
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Sepsis
Toxemia
Urinary Tract Infections
Respiratory Tract Infections
Intraabdominal Infections
Soft Tissue Infections
Emergencies
Disease Attributes
Pathologic Processes
Systemic Inflammatory Response Syndrome
Inflammation
Urologic Diseases
Respiratory Tract Diseases