Clinical trial NCT05762302: 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)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Respiratory Tract Infection
Lead sponsor: MeMed Diagnostics Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-09
Enrollment: 1316
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: There will be a pre-study implementation phase (JUNO trial), in which approximately 250 patients will be recruited. Data obtained for these patients will not be included in the analysis. The purpose of the pre-study implementation phase is to enable the participating clinicians to become familiar with the MeMed BV test. An additional purpose is to test the design and operational assumptions before the subsequent JUPITER trial.

Eligibility criteria: INCLUSION CRITERIA

* Patients eligible for inclusion are required to fulfill all of the following 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.
* Tactile fever or measured temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported), either of them 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, auscultatory abnormality (e.g. wheezing, rhonchi).
* Clinician intent to prescribe antibiotics based on the currently available data.

EXCLUSION CRITERIA

Patients fulfilling any of the following criteria are not eligible for inclusion in the infectious cohort:

* Systemic antibiotics within 72 hours prior to enrollment
* Inflammatory disease (e.g., IBD, SLE, Rheumatoid arthritis, 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 surgery, trauma and\\or burns 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.
* Patients with severe illnesses that affect life expectancy and quality of life such as end stage renal disease, end stage liver disease or severe COPD.
* Clinician intent to hospitalize patient.
* Patients with suspected concomitant infections (e.g. UTI, cellulitis, gastroenteritis, etc.)
* Active treatment with immune-suppressive or immune-modulating therapies, including without limitations:

Administration of PO\\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

•Considered unsuitable for the study by the study team

Primary outcomes:
measure: 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.
timeFrame: Through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida-Jacksonville
state: Florida
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Philadelphia
country: United States
facility: Philadelphia Thomas Jefferson Urgent Care
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University South Carolina
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Milwaukee
country: United States
facility: MCW
state: Wisconsin
city: Haifa
country: Israel
facility: Carmel Medical Center
state: North
city: Ashdod
country: Israel
facility: Samson Assuta Ashdod University Hospital
city: Haifa
country: Israel
facility: Lin Medical Center
Study officials:
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