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

NCT ID: NCT03052088

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-06
• Study Completion Date: 2019-08-01

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.

Conditions

Fever; Respiratory Tract Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Commission

OTHER

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: collaborator

University of Parma

OTHER

Sponsor Role: collaborator

MeMed Diagnostics Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tobias Tenenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Kinderklinik Universitatsmedizine mannheim

Locations

Kinderklinik Universitatsmedizin Mannheim

Mannheim, , Germany

Pietro Barilla Children's Hospital

Parma, , Italy

Countries

Germany; Italy

References

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.

Reference Type: BACKGROUND

PMID: 25785720 (View on PubMed)

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. No abstract available.

Reference Type: BACKGROUND

PMID: 27255416 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28012942 (View on PubMed)

Other Identifiers

MM-1006-AP

Identifier Type: -

Identifier Source: org_study_id