A Blood Test to Diagnose Sepsis in Symptomatic Adults and Children

Study Overview
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Brief Summary
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A case-control cohort study to develop and validate the performance of a whole blood gene expression test to distinguish sepsis infection from uninfected systemic inflammatory response syndrome cases in symptomatic adults and children without comorbidities.

Detailed Description
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The purpose of this prospective, non-interventional study is to develop and validate a blood gene expression test for diagnosing the cause of sepsis in adults and children with symptoms of infection. Sepsis affects 31.5 million people globally leading to 5.3 million deaths each year. Sepsis is particularly harmful to immunodeficient patients undergoing cancer therapy with 3.7 percent to 6.4 percent of cancer patients diagnosed with sepsis in the US in their first year after cancer diagnosis. Current tests to diagnose the infectious cause of sepsis rely on blood cultures which takes 24-48 hours to complete; leading to delays in early treatment critical to reduce the risk of developing sepsis shock and possibly death. In addition, around 50 percent of severe sepsis cases are culture negative, confounded acute infections not detected in the blood, by viral infection or uninfected patients exhibiting systemic inflammatory response syndrome (SIRS). Since sepsis often progresses to sepsis shock within 72 hours, suspected sepsis cases are usually immediately treated with antibiotics until results from testing distinguish the cause of symptoms. This leads to the over-use of antibiotics and delays appropriate treatment for those without bacterial infection or un-infected SIRS. A quick and accurate diagnostic blood test may enable early discrimination of the cause of sepsis resulting in faster more appropriate treatments and reduced sepsis complications and death. The study will collect blood samples from participants presenting symptoms of acute infection, without co-morbidities and follow symptom severity and mortality for 28 days.

Official Title
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A Cohort Study to Evaluate Biomarkers as Indicator for the Infectious Source of Sepsis Through a Blood Test

Conditions
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Infections, Sepsis, SIRS

Intervention / Treatment
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* Diagnostic Test: Diagnostic Test: Blood specimen collection


Participation Criteria
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Eligibility Criteria
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Criteria: Inclusion Criteria: Clinical suspicion of an acute infectious disease Presence of at least ONE of the following: Temperature ≥ 38°C or Temperature ≤ 36°C Heart rate > 90 bpm Respiratory rate > 20/min Self reported fever/chills Symptom duration ≤ 7 days Exclusion Criteria: Received antibiotics or antivirals in the past 2 weeks. Previous infection in previous 2 weeks Primary or secondary immunodeficiency Proven or suspected HIV, hepatitis B or hepatitis C infection Current immune-suppressive or immune-modulating treatment Active hematological malignancy Other illnesses that affect life expectancy

Ages Eligible for Study
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Minimum Age: 90 Days
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Diagnostic Test: Blood specimen collection|Diagnostic Test: Blood specimen collection Study samples must be collected within before treatment with antibiotics or antivirals.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of underlying cause of sepsis infection | The sensitivity and specificity of the assay in differentiating bacterial from viral infection. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of underlying cause of acute infection symptoms | The sensitivity and specificity of the assay in differentiating infectious and non-infectious disease. | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute infection, Fever without source, Viral infection