Host-based Immunoassay for Differentiating Bacterial From... | NCT03075111

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

NCT03075111

Sponsor

MeMed Diagnostics Ltd.

Status

Completed

Last Update Posted

Aug 4, 2022Actual

Enrollment

3,000Actual

Phase

Not provided

Conditions

Fever

Interventions

ImmunoXpert

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 7, 2015Actual

Primary Completion Date

Feb 2019Actual

Completion Date

Jul 5, 2022Actual

First Submitted Date

Mar 6, 2017

First Submission Date that Met QC Criteria

Mar 8, 2017

First Posted Date

Mar 9, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2022

Last Update Posted Date

Aug 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

3,000Actual

Name	Type	Description	Arm Group Labels	Other Names
ImmunoXpert	Diagnostic Test	Host based immune response test distinguishing viral versus bacterial infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The sensitivity and specificity of a host-response based diagnostics in differentiating between bacterial and viral etiology of patients with an acute febrile disease.		0-7 days after the initiation of symptoms

Secondary Outcomes

Measure	Description	Time Frame
The sensitivity and specificity of a host-response based diagnostics in differentiating between infectious and non-infectious disease etiology		0-7 days after the initiation of symptoms

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients aged 3 month to 18 years that were admitted due to acute febrile illness, and ImmunoDx test was taken as part of their workup.

The febrile illness should also fulfill the following criteria:

The patient had a peak temperature ≥38°C (AND)
Symptoms initiated ≤ 7 days before sampling (AND)
A retrospective diagnosis of bacterial or viral or mixed infection was anonymously determined by a panel of three independent senior pediatricians.

The non-infectious disease control group will include:

A retrospective diagnosis of a non-infectious disease was anonymously determined by a panel of three independent senior pediatricians physicians.
Patients with a non-infectious disease ( and ImmunoDx test was wrongly taken)

Exclusion Criteria:

Samples from patients who had one or more of the following criteria will be excluded from the study:
Another infection episode during the last 3 weeks before sampling
Congenital immune deficiency (CID)
A proven or suspected HIV-1, HBV, HCV infection
Active hematological 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 last two weeks
Monoclonal antibody administration
Intravenous immunoglobulin (IVIG)
Other illnesses that affect life expectancy and/or quality of life
Suspicion of gastrointestinal infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Patients with an acute bacterial infection
Patients with an acute viral infection
Patients with an acute co-infection (bacterial and viral)
Patients with an undetermined disease etiology

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical center		Hadera			Israel
Bnei Zion medical center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37916266	Derived	Klein A, Shapira M, Lipman-Arens S, Bamberger E, Srugo I, Chistyakov I, Stein M. Diagnostic Accuracy of a Real-Time Host-Protein Test for Infection. Pediatrics. 2023 Dec 1;152(6):e2022060441. doi: 10.1542/peds.2022-060441.

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms