Using MeMed BV to help manage lower respiratory infections in emergency settings
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)
This study is testing if the MeMed BV test can help doctors decide when to use antibiotics for adults with lower respiratory infections in emergency settings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1316 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | MeMed Diagnostics Ltd. Industry-sponsored |
| Drugs / interventions | Methotrexate, Cyclophosphamide, prednisone |
| Locations | 10 sites (Jacksonville, Florida and 9 other locations) |
| Trial ID | NCT05762302 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the MeMed BV test in assisting clinicians with antibiotic decision-making for patients presenting with symptoms of lower respiratory tract infections (LRTI) in emergency departments and urgent care centers. The study involves a pre-implementation phase to familiarize clinicians with the test before enrolling patients in the main trial. Participants will be adults with suspected LRTI who meet specific clinical criteria, and the study aims to assess the impact of the test on clinical outcomes, antibiotic usage, and hospitalization rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with symptoms of LRTI lasting less than 7 days and a clinician's intent to prescribe antibiotics.
Not a fit: Patients who have received systemic antibiotics within the last 72 hours or have inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate antibiotic prescribing, reducing unnecessary antibiotic use and improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using diagnostic tests to guide antibiotic use in respiratory infections, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida and 9 other locations
- University of Florida-Jacksonville — Jacksonville, Florida, United States (Recruiting)
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- Maimonides Medical Center — Brooklyn, New York, United States (Recruiting)
- Stony Brook University Hospital — Stony Brook, New York, United States (Recruiting)
- Philadelphia Thomas Jefferson ED — Philadelphia, Pennsylvania, United States (Recruiting)
- Medical University South Carolina — Charleston, South Carolina, United States (Recruiting)
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Mcw — Milwaukee, Wisconsin, United States (Recruiting)
- Carmel Medical Center — Haifa, North, Israel (Recruiting)
- Lin Medical Center — Haifa, Israel (Not_yet_recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.