The Ward Study for SeptiCyte® Lab to Distinguish Between Infection-positive and Infection-negative SIRS

Study Overview
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Brief Summary
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A non-interventional, prospective observational study to assess the performance of SeptiCyte® Lab to diagnose patients identified as suspected of sepsis in general medical and surgical wards with infection-positive from infection-negative SIRS

Detailed Description
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This study is evaluating a molecular diagnostic device developed to distinguish between sepsis and infection-negative SIRS among critically ill patients. This study is a prospective, non-randomized, non-interventional, observational trial of patients with suspected sepsis in the medical and/or surgical wards. The study is being conducted on two preselected patient care units. All patients identified by a local screening tool undergo physician review. If the suspicion of sepsis is found to be plausible, routine and conventional diagnostic procedures, including: routine bloods, blood culture and specialized tests are conducted. Blood collection for SeptiCyte® Lab and SeptID® is drawn within 6 hours of a positive screen - both use peripheral blood as the clinical sample. The diagnostic performance of the two experimental assays will be compared to Retrospective Physician Diagnosis (RPD), and conventional microbiological culture. The results of SeptiCyte® Lab and SeptID® are not used in any clinical decision-making. This data will be used to analyze the performance of SeptiCyte® Lab according to the endpoint measures.

Official Title
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To Assess the Performance of SeptiCyte® Lab to Diagnose Patients Identified as Suspected of Sepsis in General Medical and Surgical Wards With Infection-positive From Infection-negative SIRS

Conditions
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Sepsis, SIRS

Intervention / Treatment
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* Other: SeptiCyte Lab molecular diagnostic test (non-interventional)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-89 years old on the day of enrollment. Currently admitted to study designated medical or surgical ward Have a clinical suspicion of sepsis as determined by two physicians after identification by hospital screening tool. Screened positive for sepsis, severe sepsis or septic shock using the RISE2 screening tool. Completed SBAR handover (Situation, Background, Assessment, Recommendation) SIRS present as defined by the presence of two or more of the following: Temperature > 38°C or < 36°C Heart Rate > 90 beat/min Tachypnea > 20/min or PaCO2 < 32 mmHg WBC count > 12 000/mm3 or < 4 000/mm3 or > 10% immature neutrophils (bands) Exclusion Criteria: Consent not provided Patients less than 18 years of age, or 90 years of age or older. Patients for which a blood sample could not be taken within 24 hours of a physician first determining a clinical suspicion of sepsis. Patients that are not located in the designated medical or surgical ward associated with the study. Patients listed for Comfort Measures Only. Less than 2 SIRS criteria Commencement of narrow spectrum directed antibiotics prior to screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- |
|Other: SeptiCyte Lab molecular diagnostic test (non-interventional)|This is not an interventional study. Rather it involves evaluation of a molecular diagnostic test to distinguish between sepsis and infection-negative SIRS based on host response.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SeptiCyte® Lab test result versus Retrospective Physician Diagnosis (RPD) result | To validate the ability of the SeptiCyte® Lab test to correctly discriminate infection positive from infection negative SIRS in hospital ward patients with two or more SIRS criteria compared to the non-reference method of retrospective physician diagnosis (RPD). | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SeptiCyte® Lab test result versus test results for other sepsis biomarkes, including leukocytosis, bandemia, & procalcitonin | To compare SeptiCyte® Lab test scores with other clinical sepsis biomarkers to assess its ability to discriminate infection positive from infection negative SIRS. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SeptiCyte