Establish MeMed BV™ Performance for Differentiating Bacterial From Viral Infection in Suspected Acute Infection Patients (APOLLO STUDY)

Study Overview
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Brief Summary
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Prospective, multi-center, observational, blinded study, enrolling pediatric and adult subjects. Eligible ED\Urgent care and hospital admitted patients with symptoms consistent with acute bacterial or viral infection and healthy subjects will be recruited according to the eligibility criteria. Each participant will undergo a thorough investigation upon recruitment that includes documenting clinical, radiological, laboratory and microbiological information for determining their health status. Follow-up data will be collected via a phone call. Diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection will be assessed using an expert adjudication comparator method. The study will be run in a blinded fashion: site personnel will be blinded to the comparator method outcomes, and the expert panel will be blinded to the results of the index test. Results of the index test will not be revealed to the attending clinician and so will not influence patient management.

Official Title
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Prospective, Multi-Center, Observational, Blinded Study to Establish the Diagnostic Performance of the MeMed BV™ Test for Differentiating Bacterial From Viral Infection in Patients With Suspected Acute Bacterial or Viral Infection (APOLLO STUDY)

Conditions
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Acute Infection

Intervention / Treatment
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* Diagnostic Test: MeMed BV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained from the patient or his/her legal guardian. For children under 18 years old, written informed consent from the legal guardian and assent from the patient (depending on the local requirements) Over 90 days of age Clinical suspicion of acute bacterial or viral infection Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days Current disease duration ≤ 7 days Exclusion Criteria: Another unrelated episode of febrile infection within the past 2 weeks Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis >48 hours of oral antibiotic treatment >12 hours of intravenous\intramuscular antibiotic treatment HIV, HBV, or HCV infection (self-declared or known from medical records) A proven or suspected infection on presentation with Mycobacterial (e.g. Tuberculosis, MAC), parasitic or fungal (e.g. Candida, Histoplasma, Aspergillus) pathogen Active inflammatory disease (e.g. IBD, SLE, JIA, RA, Kawasaki, other vasculitis) Major trauma and\or burns in the last 7 days Major surgery in the last 7 days Congenital immune deficiency (CID) Acquired immune deficiency\modulation state including: Active malignancy Current treatment with immune-suppressive or immune-modulating therapies, including without limitations: Administration of P.O.\IV\IM high dose steroids >1mg/kg/day prednisone (or equivalent) at some point in the past 10 days or daily continuous use of steroids > 0.25 mg/kg/day in the past 7 days Monoclonal antibodies, anti-TNF agents Intravenous immunoglobulin (IVIG) Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate G/GM-CSF, Interferons Post solid organ/bone marrow transplant patients Asplenia, sickle cell disease Indwelling central venous catheter Cystic Fibrosis Pregnancy- self reported or medically known Other severe illnesses that affect life expectancy and quality of life such as: Severe psychomotor retardation Congenital metabolic disorder End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4)

Ages Eligible for Study
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Minimum Age: 90 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infectious<br>Eligible pediatric and adult patients from ED\Urgent care and hospital admitted, with symptoms consistent with acute bacterial or viral infection. | Diagnostic Test: MeMed BV<br>* The MeMed BV™ Test is an immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The test is indicated for use in patients presenting to the ED, urgent care center and inpatients with suspected acute bacterial or viral infection. The MeMed BV™ Test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection. The MeMed BV™ test is intended for in vitro diagnostic use only.<br>|
| Healthy<br>For the purpose of establishing a normal reference range. | Diagnostic Test: MeMed BV<br>* The MeMed BV™ Test is an immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The test is indicated for use in patients presenting to the ED, urgent care center and inpatients with suspected acute bacterial or viral infection. The MeMed BV™ Test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection. The MeMed BV™ test is intended for in vitro diagnostic use only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method. | Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method. | Through study completion, an average of 18 months |