Evaluation of the MeMed BV® Test in Adult Emergency Department Patients With Fever and Acute Respiratory Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- MeMed BV® test result and diagnostic concordance
研究概览
简要总结
The goal of this observational study is to compare the results of a serum biomarker called the MeMed BV®, which is approved to help differentiate between bacterial and viral respiratory infections, to clinical diagnoses of adult emergency department patients presenting with recent fever and signs or symptoms of a respiratory infection. Active participation is completed during the emergency department visit and includes drawing blood, obtaining a sputum sample, and answering survey questions.
详细描述
The MeMed BV® is a diagnostic test newly approved by the FDA to assess the likelihood of bacterial vs. viral respiratory infections based on protein biomarkers in blood. This study aims to identify the level of agreement between the results of the MeMed BV® (bacterial/viral) and the standard of care treatment received by the participant (e.g. antibiotics for patient diagnosed with bacterial pneumonia) in order to see if implementing the MeMed BV® into standard clinical care would potentially change diagnosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults presenting to the emergency department
- •Subjective or objective fever within the past 7 days
- •Signs or symptoms of upper or lower respiratory tract infection within the past 7 days
排除标准
- •Suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis
- •Active inflammatory disease
- •Congenital or acquired immune deficiency
- •Chronic fungal or parasitic infection
- •Infection with human immunodeficiency virus (HIV)
- •Hepatitis B virus (HBV)
- •Hepatitis C virus (HCV)
- •Infection with active tuberculosis (TB)
- •Significant trauma or burns in the last 7 days
- •Patients that have undergone major surgery in the last 7 days
- •Pregnancy
- •Active malignancy
结局指标
主要结局
MeMed BV® test result and diagnostic concordance
时间窗: Emergency department 1 day visit
Percent agreement between result of MeMed BV® test (bacterial or viral respiratory infection) and antibiotic prescribing by emergency medicine doctor (which implies suspected bacterial infection)
次要结局
未报告次要终点