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

Completed

• Conditions: Urinary Tract Infections; Arthritis, Infectious; Fever; Gastroenteritis; Respiratory Tract Infections

• Registration Number: NCT01911143
• Lead Sponsor: MeMed Diagnostics Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-30
• Study Start: 2013-09
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-06
• Last Update Posted: 2016-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel