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

MeMed Diagnostics Ltd.525 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

525

Conditions

Viral Infection Bacterial Infections Antibiotic Misuse Host Response Diagnostics

Interventions

ImmunoXpert™DIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Through study completion, an average of 3 years

Secondary Outcomes

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.

Time frame: 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.

Time frame: Through study completion, an average of 3 years