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

March 6, 2016 updated by: MeMed Diagnostics Ltd.

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel
        • Hillel Yaffe Medical Center
      • Haifa, Israel
        • Bnai Zion Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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:

  1. Patients with an acute bacterial infection
  2. Patients with an acute viral infection
  3. Patients with an acute mixed co-infection (bacterial and viral)
  4. Patients with a non-infectious disease (control group)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-7 days after the initiation of symptoms

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0-7 days after the initiation of symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MeMed Diagnostics Ltd.

Collaborators

University Hospital, Geneva
Bnai Zion Medical Center

Investigators

  • Study Director: Kfir Oved, Dr., MeMed Diagnostics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (Estimate)

July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

March 8, 2016

Last Update Submitted That Met QC Criteria

March 6, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM-1002-BV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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