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

MeMed Diagnostics Ltd.0 sites525 target enrollmentMay 30, 2016

ConditionsViral Infection Bacterial Infections Antibiotic Misuse Host Response Diagnostics

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Viral Infection
Sponsor: MeMed Diagnostics Ltd.
Enrollment: 525
Primary Endpoint: ImmunoXpert™ Diagnostic Performance
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

May 30, 2016

End Date

May 2020

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MeMed Diagnostics Ltd.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

ImmunoXpert™ Diagnostic Performance

Time Frame: 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 Outcomes

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)