Antibiotic Misuse, Bacterial Infections, Host Response Diagnostics, Viral Infection
Conditions
Brief summary
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)
Interventions
DIAGNOSTIC_TESTImmunoXpert™
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
Sponsors
Schneider Children's Medical Center, Israel
MeMed Diagnostics Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 18 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ImmunoXpert™ Diagnostic Performance | Through study completion, an average of 3 years | Sensitivity and specificity of ImmunoXpert™ in differentiating between bacterial and viral etiologies of pediatric patients \>3 months old with suspicion of RTI or FWS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Gastroenteritis | Through study completion, an average of 3 years | Sensitivity and specificity of ImmunoXpert in differentiating between bacterial and viral etiologies of pediatric patients \>3 months old with GE. |
| ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Urinary Tract Infection | Through study completion, an average of 3 years | Sensitivity and specificity of ImmunoXpert in differentiating between bacterial and viral etiologies of pediatric patients \>3 months old with UTI. |
Outcome results
None listed