This is a prospective clinical validation study of a novel regulatory approved (CE-IVD) diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients. The study aims to externally validate the tool's diagnostic accuracy and estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™. Additionally, statistical analysis will be performed to compare ImmunoXpert™ accuracy to current practice lab testing (e.g. WBC, CRP, and PCT) and clinical suspicion at time of requisition. Enrolled patients will be managed according to the current standard of care and per standard institutional procedures.
Who can participate
Age range
3 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Legal guardian signs an informed consent
* Documented peak temperature ≥ 38°C (100.4°F)
* Symptom duration ≤ 7 days
* Clinical suspicion of RTI (OR) fever without a clear source after clinical examination
Exclusion Criteria:
* Another episode of febrile infection within the past 2 weeks
* Antibiotic treatment of over 48 hours
* Congenital immune deficiency (CID)
* A proven or suspected HIV, HBV, HCV infection
* Active 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 past two weeks
* Monoclonal antibodies, anti-TNF agents
* Intravenous immunoglobulin (IVIG)
* Cyclosporine, Cyclophosphamide, Tacrolimus
* G/GM-CSF, Interferons
* Other severe illnesses that affect life expectancy and/or quality of life such as:
* Severe psychomotor retardation
* Post-transplant patients
* Severe congential metabolic disorder
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool, for differentiating between bacterial and viral etiologies in pediatric patients >90 days old with suspicion of RTI or FWS
Timeframe: 0-7 days after the initiation of symptoms