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)
MeMed Diagnostics Ltd.
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.
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
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
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, d…
Interventions
- Diagnostic TestMeMed BV test
Following the MeMed BV test result, the clinician will decide whether or not to prescribe an antibiotic for your condition
Locations (10)
- University of Florida-JacksonvilleJacksonville, Florida
- University of Kansas Medical CenterKansas City, Kansas
- Maimonides Medical CenterBrooklyn, New York
- Stony Brook University HospitalStony Brook, New York
- Philadelphia Thomas Jefferson EDPhiladelphia, Pennsylvania
- Medical University South CarolinaCharleston, South Carolina