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)
Lower Respiratory Tract Infection
About this trial
This is an interventional diagnostic trial for Lower Respiratory Tract Infection
Eligibility Criteria
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. Temperature ≥ 37.8°C (100°F) or tactile fever, 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, chest discomfort, auscultatory abnormality (wheezing, rhonchi). Clinician consideration or intent to prescribe antibiotics. Exclusion Criteria: Systemic antibiotics within 72 hours prior to ED/UCC presentation Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis Inflammatory disease (e.g., IBD, SLE, RA, 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 trauma and\or burns in the last 7 days Major surgery 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. Current treatment with immune-suppressive or immune-modulating therapies, at some point in the past 10 days Consider unsuitable for the study by the study team
Sites / Locations
- University of Florida-JacksonvilleRecruiting
- University of Kansas Medical CenterRecruiting
- Maimonides Medical CenterRecruiting
- Stony Brook University HospitalRecruiting
- Philadelphia Thomas Jefferson Urgent CareRecruiting
- Medical University South CarolinaRecruiting
- UT Southwestern Medical CenterRecruiting
- Carmel Medical CenterRecruiting
- Sourasky Medical Center - IchilovRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Adults with suspected Lower Respiratory Track Infection (LRTI)- The MeMed BV arm
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 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
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