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

NCT03052088 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1140

Last updated 2021-10-12

No results posted yet for this study

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

Sponsors & Collaborators

  • European Commission

    collaborator OTHER

  • Heidelberg University

    collaborator OTHER

  • University of Parma

    collaborator OTHER

  • MeMed Diagnostics Ltd.

    lead INDUSTRY

Principal Investigators

  • Tobias Tenenbaum, MD · Kinderklinik Universitatsmedizine mannheim

Eligibility

Min Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2019-06-01
Completion
2019-08-01

Countries

  • Germany
  • Italy

Study Locations

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Entities

Diseases
Companies

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 NCT03052088 on ClinicalTrials.gov