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Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients | Clinical Trials | Clareo Health

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Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients

A Multi-center, Prospective, Pilot Study to Validate the Diagnostic Accuracy and Assess the Potential Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the Emergency Department With Respiratory Tract Infection (RTI) or Fever Without Source (FWS)

NCT03052088•MeMed Diagnostics Ltd.

View on ClinicalTrials.gov

Summary

This is a prospective clinical validation study of a novel regulatory approved (CE-IVD) diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients. The study aims to externally validate the tool's diagnostic accuracy and estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™. Additionally, statistical analysis will be performed to compare ImmunoXpert™ accuracy to current practice lab testing (e.g. WBC, CRP, and PCT) and clinical suspicion at time of requisition. Enrolled patients will be managed according to the current standard of care and per standard institutional procedures.

Eligibility

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Legal guardian signs an informed consent
•Documented peak temperature ≥ 38°C (100.4°F)
•Symptom duration ≤ 7 days
•Clinical suspicion of RTI (OR) fever without a clear source after clinical examination

Exclusion Criteria

•Another episode of febrile infection within the past 2 weeks
•Antibiotic treatment of over 48 hours
•Congenital immune deficiency (CID)
•A proven or suspected HIV, HBV, HCV infection
•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
+5 more criteria

Locations (2)

Kinderklinik Universitatsmedizin Mannheim

Mannheim, Germany

Pietro Barilla Children's Hospital

Parma, Italy

Key Dates

Start Date

February 6, 2017

Primary Completion Date

June 1, 2019

Completion Date

August 1, 2019

Last Updated

October 12, 2021

Enrollment

1,140

ACTUAL participants

Conditions

FeverRespiratory Tract Infections

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Yellow Fever Immunization

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RECRUITINGNA

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Yellow Fever Vaccine

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RECRUITING

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NCT07278700

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients

Inclusion Criteria

Exclusion Criteria

A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population

VAC-SIP-YF (Vaccination- Safety & Immunogenicity During Pregnancy- Yellow Fever)

The Fever Clinic Acute Respiratory Cohort

Respiratory Infections in Young Children

Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection