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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

NCT04254991 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 525

Last updated 2020-02-05

No results posted yet for this study

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

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 & Collaborators

  • Schneider Children's Medical Center, Israel

    collaborator OTHER

  • MeMed Diagnostics Ltd.

    lead INDUSTRY

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-30
Primary Completion
2018-05-31
Completion
2020-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04254991 on ClinicalTrials.gov