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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 525 (actual)
• Sponsor: MeMed Diagnostics Ltd. · Industry
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: —

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)

Conditions

• Viral Infection
• Bacterial Infections
• Antibiotic Misuse
• Host Response Diagnostics

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-05-30
• Primary completion: 2018-05-01
• Completion: 2020-05-01
• First posted: 2020-02-05
• Last updated: 2020-02-05