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

MeMed

Status: Completed

Conditions: Fever; Respiratory Tract Infections

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03052088

MM-1006-AP

Details and patient eligibility

About

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.

Enrollment: 1,140 patients

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

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