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

N/ACompletedNCT01911143

MeMed Diagnostics Ltd.600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Fever Respiratory Tract Infections Urinary Tract Infections Gastroenteritis Arthritis, Infectious

Eligibility

Sex: ALLMin age: 1 MonthMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: The infectious disease samples should also fulfill the following criteria: * The patient had a peak temperature ≥38°C (AND) * Symptoms initiated ≤ 7 days before sampling The non-infectious disease control group will include: * Patients with a non-infectious disease Exclusion Criteria: * Another infection episode during the last 3 weeks before sampling * Congenital immune deficiency (CID) * A proven or suspected HIV-1, HBV, HCV infection * Active hematological malignancy * Current treatment with immune-suppressive or immune-modulating * Other illnesses that affect life expectancy and/or quality of life

Outcomes

Primary Outcomes

The sensitivity and specificity of the assay in differentiating between bacterial and viral etiology of patients with an acute febrile disease

We will evaluate the assay using the accuracy measures sensitivity and specificity of differentiating between bacterial and viral etiology of pediatric patients aged 1 month to 18 years with an acute febrile disease.

Time frame: 0-7 days after the initiation of symptoms

Secondary Outcomes

The sensitivity and specificity of the assay in differentiating between infectious and non-infectious disease etiology.

We will evaluate the assay using the accuracy measures sensitivity and specificity of differentiating between infectious and non-infectious disease etiology in pediatric patients aged 1 month to 18 years.