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CompletedNCT03075111Updated Aug 4, 2022

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

An observational study in Fever, sponsored by MeMed Diagnostics Ltd.. Completed at 2 sites in Israel. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by MeMed Diagnostics Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
3,000
Ages
3 Months to 18 Years
Sex
All
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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.

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Conditions studied

  • Fever

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03

Who can participate

Ages eligible
3 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

  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

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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
3,000 participants (actual)
Patient registry
No
Biospecimen retention
None retained

Interventions

  • Diagnostic testImmunoXpert

    Host based immune response test distinguishing viral versus bacterial infection

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What researchers measure

Primary outcomes

  1. The sensitivity and specificity of a host-response based diagnostics in differentiating between bacterial and viral etiology of patients with an acute febrile disease.

    Time frame: 0-7 days after the initiation of symptoms

Secondary outcomes

  1. The sensitivity and specificity of a host-response based diagnostics in differentiating between infectious and non-infectious disease etiology

    Time frame: 0-7 days after the initiation of symptoms

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Study locations

2 sites
  • Hillel Yaffe Medical center
    Hadera, Israel
  • Bnei Zion medical center
    Haifa, 31048, Israel
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03075111
Lead sponsor
MeMed Diagnostics Ltd.
Responsible party
Sponsor
First posted
Mar 9, 2017
Start date
Nov 7, 2015
Primary completion
Feb 2019
Completion
Jul 5, 2022
Last update
Aug 4, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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