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

Bacterial Infections Clinical Trial

— ROSETTA  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04254991
• Other study ID #: 0666-15-RMC
• Status: Active, not recruiting
• Start date: May 30, 2016
• Est. completion date: May 2020

Study information

• Verified date: February 2020
• Source: MeMed Diagnostics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 525
• Est. completion date: May 2020
• Est. primary completion date: May 2018
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Misuse
• Bacterial Infections
• Communicable Diseases
• Host Response Diagnostics
• Infection
• Viral Infection
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
MeMed Diagnostics Ltd.	Schneider Children's Medical Center, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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