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

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.

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Key information

Conditions

Fever Arthritis Arthritis, Infectious Body Temperature Changes Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Infections Joint Diseases Male Urogenital Diseases Musculoskeletal Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hillel Yaffe Medical Center, Hadera, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

MeMed Diagnostics Ltd.

Industry

Collaborators

Bnai Zion Medical Center
University Hospital, Geneva

Registry information

Official study 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 Febrile Disease

Acronym: PATHFINDER

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Jul 30, 2013
Registry last updated: Mar 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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