Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients

Completed

• Conditions: Respiratory Tract Infections; Fever

• Registration Number: NCT03052088
• Lead Sponsor: MeMed Diagnostics Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-06
• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-10
• Study First Posted: 2017-02-14
• Primary Completion: 2019-06-01
• Study Completion: 2019-08-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1140

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 episode of febrile infection within the past 2 weeks
• Antibiotic treatment of over 48 hours
• Congenital immune deficiency (CID)
• A proven or suspected HIV, HBV, HCV infection
• 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/or quality of life such as:
• Severe psychomotor retardation
• Post-transplant patients
• Severe congential metabolic disorder

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool, for differentiating between bacterial and viral etiologies in pediatric patients >90 days old with suspicion of RTI or FWS	0-7 days after the initiation of symptoms

Secondary Outcome Measures

Name	Time	Method
To compare ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis	0-7 days after the initiation of symptoms
To compare the diagnostic accuracy of a host-response based diagnostic to currently available lab measures (WBC, ANC, CRP and PCT), using sensitivity and specificity measures and predetermined cutoffs	0-7 days after the initiation of symptoms

Trial Locations

Locations (2)

Pietro Barilla Children's Hospital; 🇮🇹 Parma, Italy

Kinderklinik Universitatsmedizin Mannheim; 🇩🇪 Mannheim, Germany