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

NCT04254991 | Unknown

• 1 other identifier: 0666-15-RMC
• Study Type: observational
• Target: 525
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• ImmunoXpert™ Diagnostic Performance

  Sensitivity and specificity of ImmunoXpert™ in differentiating between bacterial and viral etiologies of pediatric patients \>3 months old with suspicion of RTI or FWS

  Through study completion, an average of 3 years

Secondary Outcomes (2)

• ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Gastroenteritis

  Through study completion, an average of 3 years

• ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Urinary Tract Infection

  Through study completion, an average of 3 years

Study Arms (2)

Infectious disease group

Diagnostic Test: ImmunoXpert™

Non-infectious disease group

Diagnostic Test: ImmunoXpert™

Interventions

ImmunoXpert™ 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

Infectious disease group; Non-infectious disease group

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include eligible subjects from both genders that present to the ED due to suspected RTI, FWS, GE, UTI or non-febrile non-infectious disease (Control). Each of these subjects falls 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 an undetermined disease etiology 5. Patients with a non-infectious disease (control group)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MeMed Diagnostics Ltd.: lead
• Schneider Children's Medical Center, Israel: collaborator

MeSH Terms

Conditions

Virus Diseases; Bacterial Infections

Condition Hierarchy (Ancestors)

Infections; Bacterial Infections and Mycoses

Study Design

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

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: February 5, 2020
• Study Start: May 30, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share