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Host-based Immunoassay for Differentiating Bacterial From Viral Infections (Post-marketing Study of ImmunoXpert™ - SPIRIT Study)

NCT03075111 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2022-08-04

No results posted yet for this study

Summary

This is a retrospective external field study of a novel in vitro diagnostic (IVD) assay (ImmunoXpert™).

The study will involve reviewing the medical charts of about 4500 pediatric patients that were tested using ImmunoXpert™ as part of the routine workup for acute febrile illness.

ImmunoXpert™ uses a computer algorithm to combine immunoassay measurements of three host immune proteins (TRAIL, IP-10, and CRP) present in human blood. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection.

Statistical analysis will be performed to compare the diagnostic accuracy of ImmunoXpert™ with that of current practice lab testing e.g., WBC, CRP, and PCT (whichever were taken as part of routine care) and clinical suspicion at time of requisition.

Conditions

Interventions

DIAGNOSTIC_TEST

ImmunoXpert

Host based immune response test distinguishing viral versus bacterial infection

Sponsors & Collaborators

  • MeMed Diagnostics Ltd.

    lead INDUSTRY

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-07
Primary Completion
2019-02-28
Completion
2022-07-05

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075111 on ClinicalTrials.gov