A Retrospective, Blinded Validation of a Host-response Based Diagnostics (PATHFINDER)
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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.
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 Febrile Disease
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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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 ]
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.
Secondary Outcome Measures :
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 ]
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.
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Layout table for eligibility information
Ages Eligible for Study:
1 Month to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The study population will include patients aged 1 month to 18 years of age that were sampled both during emergency department (ED) visit or during hospitalization stay and were diagnosed with an acute infectious disease or a non-infectious disease. All samples are expected to fall into one of the following categories:
Patients with an acute bacterial infection
Patients with an acute viral infection
Patients with an acute mixed co-infection (bacterial and viral)
Patients with a non-infectious disease (control group)
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
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