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

NCT03052088 | Completed DMC

• 1 other identifier: MM-1006-AP
• Study Type: observational
• Target: 1,140
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• 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

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Eligible subjects from both genders that present to the ED due to suspected RTI, or FWS. Each of these patients falls into one of the following categories: 1. Patients with an acute bacterial infection 2. Patients with an acute viral infection 3. Patients with an acute co-infection (bacterial and viral) 4. Patients with an undetermined disease etiology

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MeMed Diagnostics Ltd.: lead
• European Commission: collaborator
• Heidelberg University: collaborator
• University of Parma: collaborator

Study Sites (2)

Kinderklinik Universitatsmedizin Mannheim

Mannheim, 68167, Germany

Location

Pietro Barilla Children's Hospital

Parma, 43126, Italy

Location

Related Publications (3)

• 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.

  PMID: 25785720 BACKGROUND

• 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.

  PMID: 27255416 BACKGROUND

• 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.

  PMID: 28012942 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples

MeSH Terms

Conditions

Fever; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

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

Study Officials

• Tobias Tenenbaum, MD

  Kinderklinik Universitatsmedizine mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: February 6, 2017
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IT (1)