Clinical Trial: Validation Study for Accuracy of a Host-response Based Test for Distinguishing Infectious Etiologies
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: A Retrospective Double Center Field Study, for Validation of Accuracy of a Host-response Based Diagnostics for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients With an Acute
Brief Summary:
This is a retrospective external validation study of a novel in-vitro diagnostic (IVD) assay that will include review of medical charts of 4500 pediatric patients to whom ImmunoXpert™ test was taken as part of routine workup for acute febrile illness.
The investigated assay requires the measurement of three host-related, blood-based, protein bio-markers that will be integrated using a formula into a single score.
Based on this score, each patient is classified into one of three categories: (i) bacterial (ii) viral (iii) marginal equivocal immune response (inconclusive or non-infectious).
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.
Detailed Summary:
Sponsor: MeMed Diagnostics Ltd.
Current Primary Outcome: The sensitivity and specificity of a host-response based diagnostics in differentiating between bacterial and viral etiology of patients with an acute febrile disease. [ Time Frame: 0-7 days after the initiation of symptoms ]
Original Primary Outcome: Same as current
Current Secondary Outcome: The sensitivity and specificity of a host-response based diagnostics in differentiating between infectious and non-infectious disease etiology [ Time Frame: 0-7 days after the initiation of symptoms ]
Original Secondary Outcome: Same as current
Information By: MeMed Diagnostics Ltd.
Dates:
Date Received: March 6, 2017
Date Started: November 7, 2015
Date Completion: December 1, 2018
Last Updated: March 8, 2017
Last Verified: March 2017
