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)
NCT ID: NCT05762302
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1316 participants
INTERVENTIONAL
2023-01-31
2026-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm
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
MeMed BV 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 control arm
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
No interventions assigned to this group
Interventions
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MeMed BV test
Following the MeMed BV test result, the clinician will decide whether or not to prescribe an antibiotic for your condition
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.
* 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
* 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
18 Years
99 Years
ALL
No
Sponsors
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MeMed Diagnostics Ltd.
INDUSTRY
Responsible Party
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Locations
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University of Florida-Jacksonville
Jacksonville, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Maimonides Medical Center
Brooklyn, New York, United States
Stony Brook University Hospital
Stony Brook, New York, United States
Philadelphia Thomas Jefferson ED
Philadelphia, Pennsylvania, United States
Medical University South Carolina
Charleston, South Carolina, United States
UT Southwestern Medical Center
Dallas, Texas, United States
MCW
Milwaukee, Wisconsin, United States
Carmel Medical Center
Haifa, North, Israel
Lin Medical Center
Haifa, , Israel
Countries
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Facility Contacts
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References
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Cassini A, Hogberg LD, Plachouras D, Quattrocchi A, Hoxha A, Simonsen GS, Colomb-Cotinat M, Kretzschmar ME, Devleesschauwer B, Cecchini M, Ouakrim DA, Oliveira TC, Struelens MJ, Suetens C, Monnet DL; Burden of AMR Collaborative Group. Attributable deaths and disability-adjusted life-years caused by infections with antibiotic-resistant bacteria in the EU and the European Economic Area in 2015: a population-level modelling analysis. Lancet Infect Dis. 2019 Jan;19(1):56-66. doi: 10.1016/S1473-3099(18)30605-4. Epub 2018 Nov 5.
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Herberg JA, Kaforou M, Gormley S, Sumner ER, Patel S, Jones KD, Paulus S, Fink C, Martinon-Torres F, Montana G, Wright VJ, Levin M. Transcriptomic profiling in childhood H1N1/09 influenza reveals reduced expression of protein synthesis genes. J Infect Dis. 2013 Nov 15;208(10):1664-8. doi: 10.1093/infdis/jit348. Epub 2013 Jul 29.
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Related Links
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Antimicrobial resistance
Tackling drug-resistant infections globally: final report and recommendations
A generalizable 29-mRNA neural-network classifier for acute bacterial and viral infections
Other Identifiers
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MMD013RCT
Identifier Type: -
Identifier Source: org_study_id
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