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 (ROSETTA)

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)

Study Overview

• Status: Unknown
• Conditions: Bacterial Infections; Viral Infection; Antibiotic Misuse; Host Response Diagnostics
• Intervention / Treatment: Diagnostic test: ImmunoXpert™

• Study Type: Observational
• Enrollment (Actual): 525

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infectious disease group	Diagnostic test: 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
Non-infectious disease group	Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Gastroenteritis	Sensitivity and specificity of ImmunoXpert in differentiating between bacterial and viral etiologies of pediatric patients >3 months old with GE.	Through study completion, an average of 3 years
ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Urinary Tract Infection	Sensitivity and specificity of ImmunoXpert in differentiating between bacterial and viral etiologies of pediatric patients >3 months old with UTI.	Through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: MeMed Diagnostics Ltd.
• Collaborators: Schneider Children's Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: February 2, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Virus Diseases; Bacterial Infections
• Other Study ID Numbers: 0666-15-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No