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

Fever Clinical Trial

— AutoPilot  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052088
• Other study ID #: MM-1006-AP
• Status: Completed
• Start date: February 6, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: October 2021
• Source: MeMed Diagnostics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1140
• Est. completion date: August 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Infections
• Respiratory Tract Infections

Locations

Country	Name	City	State
Germany	Kinderklinik Universitatsmedizin Mannheim	Mannheim
Italy	Pietro Barilla Children's Hospital	Parma

Sponsors (4)

Lead Sponsor	Collaborator
MeMed Diagnostics Ltd.	European Commission, Heidelberg University, University of Parma

Countries where clinical trial is conducted

Germany,  Italy, 

References & Publications (3)

Eden E, Srugo I, Gottlieb T, Navon R, Boico O, Cohen A, Bamberger E, Klein A, Oved K. Diagnostic accuracy of a TRAIL, IP-10 and CRP combination for discriminating bacterial and viral etiologies at the Emergency Department. J Infect. 2016 Aug;73(2):177-80. doi: 10.1016/j.jinf.2016.05.002. Epub 2016 May 30. — View Citation

Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, Kriger O, Bamberger E, Fonar Y, Yacobov R, Wolchinsky R, Denkberg G, Dotan Y, Hochberg A, Reiter Y, Grupper M, Srugo I, Feigin P, Gorfine M, Chistyakov I, Dagan R, Klein A, Potasman I, Eden E. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PLoS One. 2015 Mar 18;10(3):e0120012. doi: 10.1371/journal.pone.0120012. eCollection 2015. — View Citation

van Houten CB, de Groot JAH, Klein A, Srugo I, Chistyakov I, de Waal W, Meijssen CB, Avis W, Wolfs TFW, Shachor-Meyouhas Y, Stein M, Sanders EAM, Bont LJ. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infect Dis. 2017 Apr;17(4):431-440. doi: 10.1016/S1473-3099(16)30519-9. Epub 2016 Dec 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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