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

Urinary Tract Infections Clinical Trial

— PATHFINDER  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911143
• Other study ID #: MM-1002-BV
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: March 6, 2016
• Start date: September 2013
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: MeMed Diagnostics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Bnai Zion Medical Center	Haifa

Sponsors (3)

Lead Sponsor	Collaborator
MeMed Diagnostics Ltd.	Bnai Zion Medical Center, University Hospital, Geneva

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-7 days after the initiation of symptoms	No
Secondary	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.	0-7 days after the initiation of symptoms	No