A Controlled, Blinded Study to Validate the Diagnostic Accuracy and Assess the Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the ED With Suspicion of Acute Infection

NCT ID: NCT04254991

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 525 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-30
• Study Completion Date: 2020-05-31

Brief Summary

To externally validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in pediatric patients >3 months old with suspicion of Respiratory tract infection (RTI) or Fever without Source (FWS)

Conditions

Viral Infection; Bacterial Infections; Antibiotic Misuse; Host Response Diagnostics

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Infectious disease group

ImmunoXpert™

Intervention Type: DIAGNOSTIC_TEST

The ImmunoXpert™ technology employs a biochemical assay that measures a proprietary combination of three biomarkers of the immune system coupled with pattern recognition algorithms that classify the source of an infection as bacterial or viral

Non-infectious disease group

ImmunoXpert™

Intervention Type: DIAGNOSTIC_TEST

The ImmunoXpert™ technology employs a biochemical assay that measures a proprietary combination of three biomarkers of the immune system coupled with pattern recognition algorithms that classify the source of an infection as bacterial or viral

Interventions

ImmunoXpert™

The ImmunoXpert™ technology employs a biochemical assay that measures a proprietary combination of three biomarkers of the immune system coupled with pattern recognition algorithms that classify the source of an infection as bacterial or viral

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Documented peak temperature ≥ 38°C (100.4°F) (AND)
• Symptom duration ≤ 7 days (AND)
• Clinical suspicion of RTI (OR)
• Fever without a clear source (OR)
• Acute gastroenteritis (OR)
• Urinary tract infection

Exclusion Criteria

• Antibiotic treatment of over 48 hours' duration at time of presentation
• Another episode of febrile infection within the past 2 weeks
• A proven or suspected HIV1, HBV, or HCV infection
• Congenital immune deficiency (CID)
• Active malignancy
• Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:

• Use of high dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks Monoclonal antibodies, anti-TNF agents
• Intravenous immunoglobulin (IVIG)
• Cyclosporine, Cyclophosphamide, Tacrolimus
• G/GM-CSF, Interferons
• Other severe illnesses that affect life expectancy and quality of life such as:

• Moderate to severe psychomotor retardation
• Post-transplant patients
• Moderate to severe congenital metabolic disorder

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Schneider Children's Medical Center, Israel

OTHER

Sponsor Role: collaborator

MeMed Diagnostics Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

0666-15-RMC

Identifier Type: -

Identifier Source: org_study_id