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)

NCT05762302 | Recruiting FDA Device

• 1 other identifier: MMD013RCT
• Study Type: interventional
• Target: 1,316
• Locations: 2 countries
• Sites: 10

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.

Conditions

Lower Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm

EXPERIMENTAL

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

Adults with suspected Lower Respiratory Track Infection (LRTI)- The control arm

NO INTERVENTION

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

Interventions

MeMed BV test DIAGNOSTIC_TEST

Following the MeMed BV test result, the clinician will decide whether or not to prescribe an antibiotic for your condition

Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained from the patient or his/her legal guardian.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MeMed Diagnostics Ltd.: lead

Study Sites (10)

University of Florida-Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Maimonides Medical Center

Brooklyn, New York, 11219, United States

RECRUITING

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

Philadelphia Thomas Jefferson ED

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Medical University South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MCW

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Carmel Medical Center

Haifa, North, Israel

RECRUITING

Lin Medical Center

Haifa, Israel

NOT YET RECRUITING

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Related Links

• Antimicrobial resistance
• Tackling drug-resistant infections globally: final report and recommendations
• A generalizable 29-mRNA neural-network classifier for acute bacterial and viral infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: applicable only for control arm
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 9, 2023
• Study Start: January 31, 2023
• Primary Completion: February 1, 2026
• Study Completion: February 28, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2); US (8)