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A multicenter randomized controlled trial to establish the impact of MeMed BV庐 on management of patients with suspected Lower Respiratory Tract Infections

  • Status
    Accepting Candidates
  • Age
    18 Years - 100 Years
  • Sexes
    All
  • Healthy Volunteers
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Description

To demonstrate MeMed BV庐 added value on top of standard of care in lowering unwarranted antibiotic prescribing in patients with LRTI in the ED/UCC.

Details

Protocol number 20226229

Eligibility

Inclusion

Written informed consent must be obtained from the patient or his/her legal guardian. 18 years of age or older Current disease duration 鈮� 7 days. Temperature 鈮� 37.8掳C (100掳F) (any body site, any measurement device, including self-reported) or tactile fever, 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 Chest discomfort wheezing, rhonchi

聽 Exclusion

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, 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) 聽Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate G/GM-CSF, Interferons

聽Considered unsuitable for the study by the study team

Lead researcher

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