About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
MeMed BV test
Diagnostic testFollowing the MeMed BV test result, the clinician will decide whether or not to prescribe an antibiotic for your condition
Treatment groups
Trial outcomes
Primary outcomes
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.
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).
Sponsors and contacts
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