Clinical trial NCT03075111: Host-based Immunoassay for Differentiating Bacterial From Viral Infections (Post-marketing Study of ImmunoXpert™ - SPIRIT Study)
Official title: Field Study of Host-based Immunoassay for Differentiating Bacterial From Viral Infections (Post-marketing Study of ImmunoXpert™ - SPIRIT Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Lead sponsor: MeMed Diagnostics Ltd.
Sponsor class: INDUSTRY
First posted: 2017-03-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


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

Primary outcomes:
measure: The sensitivity and specificity of a host-response based diagnostics in differentiating between bacterial and viral etiology of patients with an acute febrile disease.
timeFrame: 0-7 days after the initiation of symptoms
Secondary outcomes:
measure: The sensitivity and specificity of a host-response based diagnostics in differentiating between infectious and non-infectious disease etiology
timeFrame: 0-7 days after the initiation of symptoms
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical center
city: Haifa
country: Israel
facility: Bnei Zion medical center
Study officials:
References: