An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.

An Adjunct Test Distinguishing Bacterial From Viral Etiology Improves Resource Utilization and Efficiency in the ED.

Does an Adjunct Diagnostic Test That Can Discriminate Bacterial From Viral Etiology Early in the Management of Respiratory Infections Improve Management Accuracy and Quality in the Acute Care Setting?

The purpose of this study is to evaluate overall changes in patient management and longer-term resource utilization between control and test arms, including (but not limited to) additional work-up (including other diagnostic tests and consults), antimicrobial treatments, disposition decisions and hospital length of stay (LOS)

The trial seeks to compare the benefits of adding a diagnostic test that can distinguish the etiology of an acute respiratory illness early in the work-up and management. All adult patients shall be evaluated through the Emergency Department (ED) as an undiagnosed acute reparatory illness (URI). The included patient cohort must present with SIRS criteria and be ill enough to require immediate blood draw and management by the ED. Excluded are any URIs with a predetermined diagnosis or subjects presenting with illness not determined to be a URI as a primary diagnosis. The experimental arm of the study shall have in addition to the standard of care labs and diagnostics, a novel protein array blood test that can distinguish bacterial from viral disease. The control group will not receive these results. The trial seeks to examine the difference in clinical outcomes when a adjunct biomarker than can help the clinician guide more accurate therapy is available early in the diagnostic workup. Benefits are defined in the primary and secondary outcomes as reduced resources expended through reduced laboratory, radiological, blood bank, and pharmaceutical expenditures. Comparative resource utilization costs include changes in hospital and or ED length of stay, lower follow up visits and readmissions, less inpatient and outpatient physician consultants and services called for to manage the patients care, and overall costs. Both primary and secondary outcomes will be used to categorize the costs and resources required to manage the patient.

Statistician assessing financial and resource utilization between study arms (primary and secondary outcomes) will be blinded as to which cohort had the results of the Memed diagnostic test (experimental vs standard groups)

In addition to the standard of care for acute respiratory infections, the experimental arm shall reveal the results of the 'BV' test to the clinician co-investigators. The BV test reports a clinical score from 1-100 that as an adjunct to usual care, may help the clinician better direct appropriate resources towards the patient.

The co-investigators shall evaluate, diagnose and manage the acute respiratory infection presenting to the ED using the standard practice known in the community. This may include hospital sepsis practice protocols, clinical judgement, and national or local practice standards.

one purple top tube of whole blood (2-3 cc) to be used for the MeMed Key® device processing without the need for centrifuge. The MeMed BV® test takes approximately 15 minutes to process and result. After, the sample has been processed and the MeMed BV® test has resulted, the sample of blood will be discarded for each patient enrolled in the study.

Usual care includes diagnostic hematology, chemistry, biomarkers, and culture results along with imaging, consults, and medications, in the treatment of acute viral and/or bacterial illness.

Additional diagnostic tests may include serial complete blood count (CBC)s, additional blood cultures, viral cultures and serial basic metabolic panel (BMP) blood bank

Total costs defined as all costs including lab and diagnostic services, blood bank, pharmaceuticals, nursing, consultants, and all other services listed in the patient's work-up. Comparative metric between the experimental and control groups

Number of participants that had a bounce back as defined as patients returning any time during the 28-day call back period

Bounce backs are defined as any return to a health care entity during the 28 day period after discharge from the index visit. Comparative metric between the experimental and control groups

Medical interventions such as blood draws, consults and imaging used during the patient's time in the study

Quality of care as determined by the number of acute respiratory ill patients with bacterial etiology that received appropriate antibiotics

Upper respiratory infection (URI) cohort without a bacterial source (viral, inflammatory, etc.) who appropriately did not receive antibiotics or whose antibiotic course was withheld during the patient's time in the study

Inclusion Criteria: 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 respiratory tract infection (RTI) Blood tests are being ordered Exclusion Criteria: Systemic antibiotics taken up to 48 hours prior to presentation Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis Inflammatory disease Congenital immune deficiency (CID) A proven or suspected infection on the presentation with Mycobacterial ,parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen Human immunodeficiency virus(HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (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 Hemodynamically unstable (require life-saving interventions such as vasopressors) Patients transferred from another facility who already have a differentiated respiratory illness (known diagnosis e.g., culture positive results) Consider unsuitable for the study by the study team