Using MeMed BV to help manage lower respiratory infections in emergency settings

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of the MeMed BV test in assisting clinicians with antibiotic decision-making for patients presenting with symptoms of lower respiratory tract infections (LRTI) in emergency departments and urgent care centers. The study involves a pre-implementation phase to familiarize clinicians with the test before enrolling patients in the main trial. Participants will be adults with suspected LRTI who meet specific clinical criteria, and the study aims to assess the impact of the test on clinical outcomes, antibiotic usage, and hospitalization rates.

Why it matters

Who can join: the full rules

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, dyspnea/shortness of breath, auscultatory abnormality (e.g. wheezing, rhonchi).
* Clinician intent to prescribe antibiotics based on the currently available data.

EXCLUSION CRITERIA

Patients fulfilling any of the following criteria are not eligible for inclusion in the infectious cohort:

* 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
* HIV, HBV, or HCV infection (self-declared or known from medical records)
* Major surgery, trauma and\\or burns 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.
* Patients with severe illnesses that affect life expectancy and quality of life such as end stage renal disease, end stage liver disease or severe COPD.
* Clinician intent to hospitalize patient.
* Patients with suspected concomitant infections (e.g. UTI, cellulitis, gastroenteritis, etc.)
* Active treatment with immune-suppressive or immune-modulating therapies, 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) Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate G/GM-CSF, Interferons

•Considered unsuitable for the study by the study team

Where it's running

• Maimonides Medical Center
  Brooklyn, New York, United States Recruiting
• Stony Brook University Hospital
  Stony Brook, New York, United States Recruiting
• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Mcw
  Milwaukee, Wisconsin, United States Recruiting
• Carmel Medical Center
  Haifa, North, Israel Recruiting
• Lin Medical Center
  Haifa, Israel Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.