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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Retrospective, Blinded Validation Study to Assess the Accuracy of a Host-response Based Diagnostics for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients With an Acute Febr

Brief 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.

Detailed Summary:
Sponsor: MeMed Diagnostics Ltd.

Current Primary Outcome: The sensitivity and specificity of the assay 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 the assay 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: July 15, 2013
Date Started: September 2013
Date Completion:
Last Updated: March 6, 2016
Last Verified: March 2016