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
- Lower Respiratory Tract Infection
- Interventions
- Diagnostic Test: MeMed BV test
- Registration Number
- NCT05762302
- Lead Sponsor
- MeMed Diagnostics Ltd.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1316
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm MeMed BV test 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
- Primary Outcome Measures
Name Time Method 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. Through study completion, an average of 18 months 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
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 Urgent Care
🇺🇸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
Samson Assuta Ashdod University Hospital
🇮🇱Ashdod, Israel
Lin Medical Center
🇮🇱Haifa, Israel