The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) (JUPITER TRIAL)

Study Overview
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Brief Summary
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This is a Prospective, multi-center study enrolling adults subjects presented to the ED/Urgent care, with symptoms consistent with lower respiratory infection (LRTI). The reason of this study is to demonstrate the MeMed BV can help clinicians make decisions about using antibiotics in patients with lower respiratory track infections and see how it would impact clinical outcomes, antibiotics use, hospitalizations, ED clinicians find ways to improve health and medical care.

Official Title
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A Multicenter Randomized Controlled Trial to Establish the Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) (JUPITER TRIAL)

Conditions
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Lower Respiratory Tract Infection

Intervention / Treatment
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* Diagnostic Test: MeMed BV test


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. 18 years of age or older. Current disease duration ≤ 7 days. Temperature ≥ 37.8°C (100°F) or tactile fever, noted at least once within the last 7 days. Clinical suspicion of bacterial or viral LRTI: At least one of the following respiratory signs or symptoms: cough (new or worsening), sputum production, dyspnea, shortness of breath, chest discomfort, auscultatory abnormality (wheezing, rhonchi). Clinician consideration or intent to prescribe antibiotics. Exclusion Criteria: Systemic antibiotics within 72 hours prior to ED/UCC presentation Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis Inflammatory disease (e.g., IBD, SLE, RA, Kawasaki, other vasculitis) Congenital immune deficiency (CID) A proven or suspected infection on presentation with Mycobacterial (e.g., MAC, MABC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen HIV, HBV, or HCV infection (self-declared or known from medical records) Major trauma and\or burns in the last 7 days Major surgery in the last 7 days Pregnancy- self reported or medically confirmed Active malignancy - Cancer diagnosed within the previous six months, recurrent, regionally advanced or metastatic cancer, cancer for which treatment had been administered within six months, or hematological cancer that is not in complete remission. Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days Consider unsuitable for the study by the study team

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm<br>ED and urgent care center patients over the age of 18 years , with clinical suspicion of Lower Respiratory Track Infection. clinician will receive the BV result, this will include a recommendation regarding antibiotic treatment. A telephone FU call will be done at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness | Diagnostic Test: MeMed BV test<br>* Following the MeMed BV test result, the clinician will decide whether or not to prescribe an antibiotic for your condition<br>|
| No Intervention: Adults with suspected Lower Respiratory Track Infection (LRTI)- The control arm<br>ED and urgent care center patients over the age of 18 years , with clinical suspicion of Lower Respiratory Track Infection. clinician will not receive the BV result, and will treat according to standard of care. A telephone FU call will be done at 28 (+/- 3) days after the day of consent to complete a short questionnaire regarding your current illness | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate MeMed BV® added value on top of standard of care in lowering unwarranted antibiotic prescribing in patients with LRTI in the ED/UCC. | Primary outcome is total antibiotic prescription in the ED/UCC in the BV and control arms, defined as antibiotic initiation by the initial ED/UCC clinician (reached if the patient received antibiotics during ED/UCC visit). | Through study completion, an average of 18 months |