NCT03052088

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

A Multi-center, Prospective, Pilot Study to Validate the Diagnostic Accuracy and Assess the Potential Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the Emergency Department With Respiratory Tract Infection (RTI) or Fever Without Source (FWS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,140 (actual)
• Sponsor: MeMed Diagnostics Ltd. · Industry
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Fever
• Respiratory Tract Infections

Timeline

• Start date: 2017-02-06
• Primary completion: 2019-06-01
• Completion: 2019-08-01
• First posted: 2017-02-14
• Last updated: 2021-10-12

Locations

2 sites across 2 countries: Germany, Italy