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

Recruiting
18 years of age
Both
Phase N/A

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Overview

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

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:

  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.

Study details

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

NCT04094818

Inflammatix

26 January 2024

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