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

NCT04094818 | Completed

• 1 other identifier: INF-04
• Study Type: observational
• Target: 1,441
• Locations: 2 countries
• Sites: 26

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.

Conditions

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

Keywords

Infection; mRNA; Procalcitonin; C-Reactive Protein; Lactate

Outcome Measures

Primary Outcomes (3)

• Evaluation of the diagnostic performance of HostDx Sepsis

  Concordance of HostDx Sepsis bacterial readout with clinical adjudication

  28 Days After Enrollment

• Evaluation of the diagnostic performance of HostDx Sepsis

  Concordance of HostDx Sepsis viral readout with clinical adjudication

  28 Days After Enrollment

• Evaluation of the prognostic performance of HostDx Sepsis

  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))

  7 Days After Enrollment

Secondary Outcomes (2)

• Evaluation of the prognostic performance of HostDx Sepsis

  28 Days after enrollment

• Evaluation of the prognostic performance of HostDx Sepsis for 28-Day Hospital Mortality

  28 Days after enrollment

Interventions

TriVerity DIAGNOSTIC_TEST

Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection and sputum/ BAL sample collection

Also known as: InSep, HostDx Sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Age \>18 year
• 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
• Able to provide informed consent, or consent by legally authorized representative.

You may not qualify if:

• Participants will be ineligible for this study if they meet any of the following criteria:
• 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:
• 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 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
• Patients receiving palliative or hospice care, or those receiving limited interventional care.
• 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.
• 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.
• Patients previously enrolled in the present clinical trial.

Sponsors & Collaborators

• Inflammatix: lead

Study Sites (26)

University of South Alabama

Mobile, Alabama, 36617, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

Medstar Health Research Institute

Washington D.C., District of Columbia, 20010, United States

Location

University of Florida (UF) - Jacksonville

Jacksonville, Florida, 32209, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21209, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Essentia Institute of Rural Health

Duluth, Minnesota, 55805, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Hackensack Meridian Health

Montclair, New Jersey, 07042, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Oklahoma University Health

Oklahoma City, Oklahoma, 73104, United States

Location

Geisinger Health

Danville, Pennsylvania, 17822, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Texas Tech University Health Sciences Center - El Paso

El Paso, Texas, 79905, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

ATTIKON University Hospital

Athens, Greece

Location

Related Publications (12)

• Gaieski DF, Mikkelsen ME, Band RA, Pines JM, Massone R, Furia FF, Shofer FS, Goyal M. Impact of time to antibiotics on survival in patients with severe sepsis or septic shock in whom early goal-directed therapy was initiated in the emergency department. Crit Care Med. 2010 Apr;38(4):1045-53. doi: 10.1097/CCM.0b013e3181cc4824.

  PMID: 20048677 BACKGROUND

• Ferrer R, Martin-Loeches I, Phillips G, Osborn TM, Townsend S, Dellinger RP, Artigas A, Schorr C, Levy MM. Empiric antibiotic treatment reduces mortality in severe sepsis and septic shock from the first hour: results from a guideline-based performance improvement program. Crit Care Med. 2014 Aug;42(8):1749-55. doi: 10.1097/CCM.0000000000000330.

  PMID: 24717459 BACKGROUND

• Mi MY, Klompas M, Evans L. Early Administration of Antibiotics for Suspected Sepsis. N Engl J Med. 2019 Feb 7;380(6):593-596. doi: 10.1056/NEJMclde1809210. No abstract available.

  PMID: 30726686 BACKGROUND

• Singer M. Biomarkers in sepsis. Curr Opin Pulm Med. 2013 May;19(3):305-9. doi: 10.1097/MCP.0b013e32835f1b49.

  PMID: 23411577 BACKGROUND

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Coburn B, Morris AM, Tomlinson G, Detsky AS. Does this adult patient with suspected bacteremia require blood cultures? JAMA. 2012 Aug 1;308(5):502-11. doi: 10.1001/jama.2012.8262.

  PMID: 22851117 BACKGROUND

• Gunsolus IL, Sweeney TE, Liesenfeld O, Ledeboer NA. Diagnosing and Managing Sepsis by Probing the Host Response to Infection: Advances, Opportunities, and Challenges. J Clin Microbiol. 2019 Jun 25;57(7):e00425-19. doi: 10.1128/JCM.00425-19. Print 2019 Jul.

  PMID: 31043466 BACKGROUND

• Sweeney TE, Shidham A, Wong HR, Khatri P. A comprehensive time-course-based multicohort analysis of sepsis and sterile inflammation reveals a robust diagnostic gene set. Sci Transl Med. 2015 May 13;7(287):287ra71. doi: 10.1126/scitranslmed.aaa5993.

  PMID: 25972003 BACKGROUND

• Sweeney TE, Wong HR, Khatri P. Robust classification of bacterial and viral infections via integrated host gene expression diagnostics. Sci Transl Med. 2016 Jul 6;8(346):346ra91. doi: 10.1126/scitranslmed.aaf7165.

  PMID: 27384347 BACKGROUND

• Sweeney TE, Perumal TM, Henao R, Nichols M, Howrylak JA, Choi AM, Bermejo-Martin JF, Almansa R, Tamayo E, Davenport EE, Burnham KL, Hinds CJ, Knight JC, Woods CW, Kingsmore SF, Ginsburg GS, Wong HR, Parnell GP, Tang B, Moldawer LL, Moore FE, Omberg L, Khatri P, Tsalik EL, Mangravite LM, Langley RJ. A community approach to mortality prediction in sepsis via gene expression analysis. Nat Commun. 2018 Feb 15;9(1):694. doi: 10.1038/s41467-018-03078-2.

  PMID: 29449546 BACKGROUND

• Sweeney TE, Khatri P. Benchmarking Sepsis Gene Expression Diagnostics Using Public Data. Crit Care Med. 2017 Jan;45(1):1-10. doi: 10.1097/CCM.0000000000002021.

  PMID: 27681387 BACKGROUND

• Whitfield NN, Hogan CA, Chenoweth J, Hansen J, Hsu EB, Humphries R, Mann E, May L, Michelson EA, Rothman R, Self WH, Smithline HA, Karita HCS, Steingrub JS, Swedien D, Weissman A, Wright DW, Liesenfeld O, Shapiro NI. A standardized protocol using clinical adjudication to define true infection status in patients presenting to the emergency department with suspected infections and/or sepsis. Diagn Microbiol Infect Dis. 2024 Sep;110(1):116382. doi: 10.1016/j.diagmicrobio.2024.116382. Epub 2024 May 31.

  PMID: 38850687 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

PAXgene RNA tubes containing whole blood

MeSH Terms

Conditions

Respiratory Tract Infections; Urinary Tract Infections; Intraabdominal Infections; Soft Tissue Infections; Encephalitis; Sepsis; Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: February 28, 2020
• Primary Completion: August 6, 2024
• Study Completion: September 30, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (25); GR (1)