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

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.

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Key information

Conditions

Fever Body Temperature Changes Infections Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms

Age range

3 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kinderklinik Universitatsmedizin Mannheim, Mannheim, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
G/GM-CSF, Interferons
Other severe illnesses that affect life expectancy and/or quality of life such as:
Severe psychomotor retardation
Post-transplant patients
Severe congential metabolic disorder

Treatment and study plan

Primary outcomes

To validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool, for differentiating between bacterial and viral etiologies in pediatric patients >90 days old with suspicion of RTI or FWS

Time frame: 0-7 days after the initiation of symptoms

Secondary outcomes

To compare the diagnostic accuracy of a host-response based diagnostic to currently available lab measures (WBC, ANC, CRP and PCT), using sensitivity and specificity measures and predetermined cutoffs

Time frame: 0-7 days after the initiation of symptoms
To compare ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis

Time frame: 0-7 days after the initiation of symptoms

Sponsors and collaborators

Lead sponsor

MeMed Diagnostics Ltd.

Industry

Collaborators

European Commission
Heidelberg University
University of Parma

Registry information

Official study title

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)

Acronym: AutoPilot

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Feb 14, 2017
Registry last updated: Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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