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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01911143

Acronym

PATHFINDER

Enrollment

600

Registered

2013-07-30

Start date

2013-09-30

Completion date

2015-08-31

Last updated

2016-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Infectious, Fever, Gastroenteritis, Respiratory Tract Infections, Urinary Tract Infections

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

Healthy volunteers

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

Design outcomes

Primary

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

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

Countries

Israel

Outcome results