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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by MeMed Diagnostics Ltd.
Sponsor:
Information provided by (Responsible Party):
MeMed Diagnostics Ltd.
ClinicalTrials.gov Identifier:
NCT01911143
First received: July 15, 2013
Last updated: January 10, 2014
Last verified: January 2014
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by MeMed Diagnostics Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

Serum samples


Estimated Enrollment: 700
Study Start Date: September 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911143

Locations
Israel
Hillel Yaffe Medical Center Recruiting
Hadera, Israel
Contact: Ester Pri-Or, RN       EsterP@hy.health.gov.il   
Principal Investigator: Adi Klein-Kremer, Dr.         
Bnai Zion Medical Center Active, not recruiting
Haifa, Israel
Sponsors and Collaborators
MeMed Diagnostics Ltd.
  More Information

No publications provided

Responsible Party: MeMed Diagnostics Ltd.
ClinicalTrials.gov Identifier: NCT01911143     History of Changes
Other Study ID Numbers: MM-1002-BV
Study First Received: July 15, 2013
Last Updated: January 10, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Arthritis, Infectious
Arthritis
Communicable Diseases
Infection
Gastroenteritis
Respiratory Tract Infections
Urinary Tract Infections
Joint Diseases
Musculoskeletal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Respiratory Tract Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 29, 2014