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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03052088

Acronym

AutoPilot

Enrollment

1140

Registered

2017-02-14

Start date

2017-02-06

Completion date

2019-08-01

Last updated

2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Respiratory Tract Infections

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

3 Months to No maximum

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 * 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

Design outcomes

Primary

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

Secondary

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

Countries

Germany, Italy

Outcome results