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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: HostDx Sepsis


Participation Criteria
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Eligibility Criteria
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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: 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). 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. Previously enrolled in the present clinical trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: HostDx Sepsis|Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)) within 7 days OR 28-Day Hospital Mortality | 28 Days after enrollment | 
| Evaluation of the prognostic performance of HostDx Sepsis for 28-Day Hospital Mortality | Concordance of HostDx Sepsis severity readout with 28-Day Hospital Mortality | 28 Days after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infection, mRNA, Procalcitonin, C-Reactive Protein, Lactate