NCT04254991UnknownNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- MeMed Diagnostics Ltd.
- Enrollment
- 525
- Primary Endpoint
- ImmunoXpert™ Diagnostic Performance
Study Overview
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)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Time Frame: 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 Outcomes
- ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Gastroenteritis(Through study completion, an average of 3 years)
- ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Urinary Tract Infection(Through study completion, an average of 3 years)
Investigators
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