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

• Conditions: Antibiotic Misuse; Host Response Diagnostics; Bacterial Infections; Viral Infection
• Interventions: Diagnostic Test: ImmunoXpert™

• Registration Number: NCT04254991
• Lead Sponsor: MeMed Diagnostics Ltd.

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-30
• Primary Completion: 2018-05
• Study First Submitted: 2020-01-07
• Status Verified: 2020-02
• Study First Submitted QC: 2020-02-02
• Last Update Submitted: 2020-02-02
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Study Completion: 2020-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 525

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infectious disease group	ImmunoXpert™	-
Non-infectious disease group	ImmunoXpert™	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.