Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients

Study Overview
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Brief Summary
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This is a prospective clinical validation study of a novel regulatory approved (CE-IVD) diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients. The study aims to externally validate the tool's diagnostic accuracy and estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™. Additionally, statistical analysis will be performed to compare ImmunoXpert™ accuracy to current practice lab testing (e.g. WBC, CRP, and PCT) and clinical suspicion at time of requisition. Enrolled patients will be managed according to the current standard of care and per standard institutional procedures.

Official Title
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A Multi-center, Prospective, Pilot Study to Validate the Diagnostic Accuracy and Assess the Potential Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the Emergency Department With Respiratory Tract Infection (RTI) or Fever Without Source (FWS)

Conditions
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Fever, Respiratory Tract Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Legal guardian signs an informed consent Documented peak temperature ≥ 38°C (100.4°F) Symptom duration ≤ 7 days Clinical suspicion of RTI (OR) fever without a clear source after clinical examination Exclusion Criteria: Another episode of febrile infection within the past 2 weeks Antibiotic treatment of over 48 hours Congenital immune deficiency (CID) A proven or suspected HIV, HBV, HCV infection 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/or quality of life such as: Severe psychomotor retardation Post-transplant patients Severe congential metabolic disorder

Ages Eligible for Study
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Minimum Age: 3 Months

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool, for differentiating between bacterial and viral etiologies in pediatric patients >90 days old with suspicion of RTI or FWS |  | 0-7 days after the initiation of symptoms | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the diagnostic accuracy of a host-response based diagnostic to currently available lab measures (WBC, ANC, CRP and PCT), using sensitivity and specificity measures and predetermined cutoffs |  | 0-7 days after the initiation of symptoms | 
| To compare ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis |  | 0-7 days after the initiation of symptoms |