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ROSETTA: 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

Sponsor
MeMed Diagnostics Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04254991
Collaborator
Schneider Children's Medical Center, Israel (Other)
525
Enrollment
47
Anticipated Duration (Months)

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ImmunoXpert™

Study Design

Study Type:
Observational
Actual Enrollment :
525 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date :
May 30, 2016
Actual Primary Completion Date :
May 1, 2018
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. ImmunoXpert™ Diagnostic Performance [Through study completion, an average of 3 years]

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

Secondary Outcome Measures

  1. ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Gastroenteritis [Through study completion, an average of 3 years]

    Sensitivity and specificity of ImmunoXpert in differentiating between bacterial and viral etiologies of pediatric patients >3 months old with GE.

  2. ImmunoXpert™ Diagnostic Performance in Pediatric Patients with Urinary Tract Infection [Through study completion, an average of 3 years]

    Sensitivity and specificity of ImmunoXpert in differentiating between bacterial and viral etiologies of pediatric patients >3 months old with UTI.

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 18 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MeMed Diagnostics Ltd.
ClinicalTrials.gov Identifier:
NCT04254991
Other Study ID Numbers:
  • 0666-15-RMC
First Posted:
Feb 5, 2020
Last Update Posted:
Feb 5, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infections
Communicable Diseases
Bacterial Infections
Virus Diseases

Study Results

No Results Posted as of Feb 5, 2020