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Completed

NCT Number: NCT04094818

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

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.

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Key information

Conditions

Respiratory Tract Infections Brain Diseases Central Nervous System Diseases Encephalitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Intra-Abdominal Infections Intraabdominal Infections Male Urogenital Diseases Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sepsis Skin and Soft Tissue Infection Soft Tissue Infections Suspected Meningitis/Encephalitis or Any Other Infection Systemic Inflammatory Response Syndrome Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ATTIKON University Hospital, Athens, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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.

Treatment and study plan

TriVerity

Diagnostic Test

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

Other names: InSep, HostDx Sepsis

Primary outcomes

  1. Evaluation of the diagnostic performance of HostDx Sepsis

    Time frame: 28 Days After Enrollment

    Concordance of HostDx Sepsis bacterial readout with clinical adjudication

  2. Evaluation of the diagnostic performance of HostDx Sepsis

    Time frame: 28 Days After Enrollment

    Concordance of HostDx Sepsis viral readout with clinical adjudication

  3. Evaluation of the prognostic performance of HostDx Sepsis

    Time frame: 7 Days After Enrollment

    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))

Secondary outcomes

  1. Evaluation of the prognostic performance of HostDx Sepsis

    Time frame: 28 Days after enrollment

    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)) within 7 days OR 28-Day Hospital Mortality

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

    Time frame: 28 Days after enrollment

    Concordance of HostDx Sepsis severity readout with 28-Day Hospital Mortality

Sponsors and collaborators

Lead sponsor

Inflammatix

Industry

Registry information

Acronym: SEPSIS-SHIELD

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2019
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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