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

UnknownOBSERVATIONAL
Enrollment

525

Participants

Timeline

Start Date

May 30, 2016

Primary Completion Date

May 31, 2018

Study Completion Date

May 31, 2020

Conditions
Viral InfectionBacterial InfectionsAntibiotic MisuseHost Response Diagnostics
Interventions
DIAGNOSTIC_TEST

ImmunoXpert™

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
All Listed Sponsors
collaborator

Schneider Children's Medical Center, Israel

OTHER

lead

MeMed Diagnostics Ltd.

INDUSTRY

NCT04254991 - 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 | Biotech Hunter | Biotech Hunter