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

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

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)

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