FeverNCT03075111
Host-based Immunoassay for Differentiating Bacterial From Viral Infections (Post-marketing Study of ImmunoXpert™ - SPIRIT Study)
An observational study of Fever, run by MeMed Diagnostics Ltd. at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Fever
- What is being tested?
- ImmunoXpert
- How many people
- 3,000 participants
- Where
- 2 sitesIsrael
- Study dates
- 7 Nov 2015to 5 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hillel Yaffe Medical center
Hadera
Bnei Zion medical center
Haifa, 31048
About this study
Official title: Field Study of Host-based Immunoassay for Differentiating Bacterial From Viral Infections (Post-marketing Study of ImmunoXpert™ - SPIRIT Study)
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.
Read more
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
- Fever
- Being tested
- ImmunoXpert
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunoXpertDiagnostic test
Host based immune response test distinguishing viral versus bacterial infection
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of a host-response based diagnostics in differentiating between bacterial and viral etiology of patients with an acute febrile disease.
Measured: 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
Measured: 0-7 days after the initiation of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start7 Nov 2015
- Primary completionFeb 2019
- Study completion5 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- MeMed Diagnostics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075111
- Sponsor's protocol ID
- MM-1007-SP
- Status last verified
- Aug 2022
- First submitted
- 6 Mar 2017
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37916266
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Study of Host-based Immunoassay for Differentiating Bacterial From Viral Infections (Post-marketing Study of ImmunoXpert™ - SPIRIT Study)
- ClinicalTrials.gov ID
- NCT03075111
- Acronym / sponsor ID
- MM-1007-SP
- Conditions
- Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- MeMed Diagnostics Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Nov 2015 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- 5 Jul 2022 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (8 listed)
- 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 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.
- A retrospective diagnosis of a non-infectious disease was anonymously determined by a panel of three independent senior pediatricians physicians.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmunoXpertHost based immune response test distinguishing viral versus bacterial infection | Diagnostic test | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Derived from this study: PubMed 37916266Klein 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.
- Individual participant dataSharing planned: No
Related trials for Fever
Not yet recruitingPhase 1/2
Effect of Temperature Elevation on the Antimicrobial Efficacy of Two Root Canal Irrigants in Primary Root Canal Infections: A Randomized Controlled Clinical Trial
Irreversible Pulpitis
Active, not recruitingPhase 1
A Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health
Marburg Virus Disease
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Not yet recruitingPhase 2
Curcumin Extract Added to Ciprofloxacin for Typhoid Carriers Among Food Handlers of the Free Nutritious Meal Program
Typhoid Carrier, Typhoid Fever
RecruitingObservational study
Natural History of Trisomy 8-Associated Autoinflammatory Disease (TRIAD) and Related Disorders
Trisomy 8 Mosaicism, Trisomy 8 Associated Autoinflammatory Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fever, run by MeMed Diagnostics Ltd. at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 0-7 days after the initiation of symptoms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.