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

• Sponsor: MeMed Diagnostics Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03052088
• Collaborator: European Commission (Other), Heidelberg University (Other), University of Parma (Other)
• Enrollment: 1,140
• Locations: 2
• Actual Duration (Months): 29.8
• Patients Per Site: 570
• Patients Per Site Per Month: 19.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fever; Respiratory Tract Infections

Study Design

• Study Type: Observational
• Actual Enrollment: 1140 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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)
• Actual Study Start Date: Feb 6, 2017
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kinderklinik Universitatsmedizin Mannheim	Mannheim		Germany	68167
2	Pietro Barilla Children's Hospital	Parma		Italy	43126

Sponsors and Collaborators

• MeMed Diagnostics Ltd.
• European Commission
• Heidelberg University
• University of Parma

Investigators

• Principal Investigator: Tobias Tenenbaum, MD, Kinderklinik Universitatsmedizine mannheim

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: MeMed Diagnostics Ltd.
• ClinicalTrials.gov Identifier: NCT03052088
• Other Study ID Numbers: MM-1006-AP
• First Posted: Feb 14, 2017
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Respiratory Tract Infections; Fever

Study Results

No Results Posted as of Oct 12, 2021