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A Retrospective, Blinded Validation of a Host-response Based Diagnostics

NCT01911143 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2016-03-08

No results posted yet for this study

Summary

This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients. The investigated assay measures the levels of a few host-related, blood-based, bio-markers that will be integrated into a single score. Based on this score, each patient will be classified into one of three categories: (i) bacterial immune response, (ii) viral immune response, and (iii) marginal immune response. The assay prediction and the patient diagnosis will than be unveiled and compared to determine their level of concordance.

Conditions

Sponsors & Collaborators

  • Bnai Zion Medical Center

    collaborator OTHER_GOV

  • University Hospital, Geneva

    collaborator OTHER

  • MeMed Diagnostics Ltd.

    lead INDUSTRY

Principal Investigators

  • Kfir Oved, Dr. · MeMed Diagnostics Ltd.

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Israel

Study Locations

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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 NCT01911143 on ClinicalTrials.gov