CLINICAL STUDY 

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Multi-center, Prospective, Study to Validate the Accuracy and Assess the Clinical Utility of a Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the Emergency Department

Purpose

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.

Primary Outcome Measures

Sensitivity and specificity of the assay in differentiating between bacterial and viral etiologies of pediatric patients >90 days old with suspicion of respiratory tract infection or fever without source. 

Secondary Outcome Measures

 

Sensitivity and specificity of ANC, WBC, CRP, and PCT in differentiating between bacterial and viral etiologies of pediatric patients >90 days old with suspicion of respiratory tract infection or fever without source. 

Study Population

Eligible subjects from both genders, aged 3 months - 18 years, which present to the ED due to suspected RTI, or FWS.

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 infection episode during the last 3 weeks before sampling

  • Congenital immune deficiency (CID)

  • A proven or suspected HIV, HBV, HCV infection

  • Active hematological malignancy

  • Current treatment with immune-suppressive or immune-modulating

  • Other illnesses that affect life expectancy and/or quality of life

ClinicalTrials.gov Identifier

NCT03052088 - Diagnostic Accuracy of a Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients (AutoPilot)

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