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

NCT01911143 | Completed

• 1 other identifier: MM-1002-BV
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• The sensitivity and specificity of the assay in differentiating between infectious and non-infectious disease etiology.

  0-7 days after the initiation of symptoms

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MeMed Diagnostics Ltd.: lead
• Bnai Zion Medical Center: collaborator
• University Hospital, Geneva: collaborator

Study Sites (2)

Hillel Yaffe Medical Center

Hadera, Israel

Location

Bnai Zion Medical Center

Haifa, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Kfir Oved, Dr.

  MeMed Diagnostics Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 30, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 8, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)