A Controlled, Blinded Study to Validate the Diagnostic Accuracy and Assess the Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the ED With Suspicion of Acute Infection

Study Overview
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Brief Summary
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To externally validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in pediatric patients >3 months old with suspicion of Respiratory tract infection (RTI) or Fever without Source (FWS)

Official Title
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A Controlled, Blinded Study to Validate the Diagnostic Accuracy and Assess the Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the ED With Suspicion of Acute Infection

Conditions
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Viral Infection, Bacterial Infections, Antibiotic Misuse, Host Response Diagnostics

Intervention / Treatment
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* Diagnostic Test: ImmunoXpert™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented peak temperature ≥ 38°C (100.4°F) (AND) Symptom duration ≤ 7 days (AND) Clinical suspicion of RTI (OR) Fever without a clear source (OR) Acute gastroenteritis (OR) Urinary tract infection Exclusion Criteria: Antibiotic treatment of over 48 hours' duration at time of presentation Another episode of febrile infection within the past 2 weeks A proven or suspected HIV1, HBV, or HCV infection Congenital immune deficiency (CID) Active malignancy Current treatment with immune-suppressive or immune-modulating therapies, including without limitations: Use of high dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks Monoclonal antibodies, anti-TNF agents Intravenous immunoglobulin (IVIG) Cyclosporine, Cyclophosphamide, Tacrolimus G/GM-CSF, Interferons Other severe illnesses that affect life expectancy and quality of life such as: Moderate to severe psychomotor retardation Post-transplant patients Moderate to severe congenital metabolic disorder

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infectious disease group<br> | Diagnostic Test: ImmunoXpert™<br>* The ImmunoXpert™ technology employs a biochemical assay that measures a proprietary combination of three biomarkers of the immune system coupled with pattern recognition algorithms that classify the source of an infection as bacterial or viral<br>|
| Non-infectious disease group<br> | Diagnostic Test: ImmunoXpert™<br>* The ImmunoXpert™ technology employs a biochemical assay that measures a proprietary combination of three biomarkers of the immune system coupled with pattern recognition algorithms that classify the source of an infection as bacterial or viral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ImmunoXpert™ Diagnostic Performance | Sensitivity and specificity of ImmunoXpert™ in differentiating between bacterial and viral etiologies of pediatric patients >3 months old with suspicion of RTI or FWS | Through study completion, an average of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Gastroenteritis | Sensitivity and specificity of ImmunoXpert in differentiating between bacterial and viral etiologies of pediatric patients >3 months old with GE. | Through study completion, an average of 3 years | 
| ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Urinary Tract Infection | Sensitivity and specificity of ImmunoXpert in differentiating between bacterial and viral etiologies of pediatric patients >3 months old with UTI. | Through study completion, an average of 3 years |