[BFD-RST-23-004] Rapid Diagnosis of Viral Acute Respiratory Infection to Decrease Unnecessary Antibiotic Utilization in the Emergency Department (RADIATE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Antibiotic Use
研究概览
简要总结
The study titled " The Effect of Definitive Identification of Viral Etiology in Emergency Department Patients with Acute Respiratory Infection on Antibiotic Utilization (RADIATE)" aims to investigate the effectiveness of a rapid diagnostic approach in reducing unnecessary antibiotic use in the emergency department (ED) for patients presenting with acute respiratory illness (ARI) due to a virus. Using a prospective design, eligible participants are individuals who visit the ED with complaints related to acute respiratory illness. The study will employ a single-arm consecutive enrollment approach. The intervention involves the implementation of a rapid point-of-care multiplex polymerase chain reaction (PCR) test to promptly identify the viral cause of the infection. By utilizing a rapid diagnostic tool to identify viral etiology, the study aims to provide healthcare professionals in the ED with more accurate information to guide treatment decisions. Ultimately, the goal is to decrease the unnecessary use of antibiotics for ARI's due to a virus, which has several negative outcomes including promotion of antibiotic resistance, exacerbating ED length of stay and encouraging unnecessary additional diagnostic tests.
详细描述
This prospective single-center, single-arm clinical trial will be conducted to study the initiation of a new diagnostic pathway for acute respiratory illness. After confirming eligibility following ED triage, patients will be enrolled to undergo the Spotfire syndromic assessment (Biomerieux, Inc.). Samples for the test will be collected via a nasopharyngeal swab administered by triage nurse or ED technician in triage. Results from test will be available in approximately 15 minutes. Patients with signs and symptoms of sore throat determined by throat pain or exudates on tonsils will also be tested for Group A streptococcus at enrollment.
Prior to enrollment, the research team asked the initial clinician to delay ordering additional tests until the test was resulted.
Patients who present to the ED with complaints of ARI will be considered eligible for the study. The intervention involves the use of a rapid point-of-care multiplex PCR test (Spotfire) to identify etiology of patients with ARI. Specimen samples will be collected by research staff at the time of ED presentation. Upon collection, the sample will be promptly prepared for testing on the SPOTFIRE R Panel device. The device will be in the ED to facilitate testing and accelerate delivery of diagnostic results to clinicians. The time when the provider receives the results will be recorded to evaluate the incorporation of results in clinical decision making.
For providers who do prescribe antibiotics, the investigators will ask for rationale for antibiotic prescription. Possible causes include: (1) concern for non-respiratory co-infection; (2) concern for respiratory co-infection. (3) patient request; (4) mitigation of legal risk. (5) significant co-morbidities. (6) personal preference / long-standing practice. (7) considered local standard of care. (8) other. In addition to questions above, investigators will specifically ask if physician was more likely to give antibiotics because the viral test was negative.
Patients will also be queried about why they came to the ED including if they had a specific intention to receive antibiotics, additional testing or other reasons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Over the age of 18
- •Clinical suspicion of an acute respiratory infection by an emergency department provider
- •Patient endorses at least ONE symptom of respiratory illness including: cough, sneezing, runny or stuffy nose, sore throat, headaches, muscle aches, trouble breathing, shortness of breath, fever
- •Patient reports symptoms lasting less than 14 days (i.e., no chronic symptoms)
- •Patient able to provide informed consent
排除标准
- •Patient is a prisoner or ward of state
- •Patients that will get antibiotics regardless of of the results of the test (e.g. sepsis, hypoxia, shock, lobar pneumonia, altered mental status, meningitis, pyelonephritis, appendicitis or related, high clinical severity not otherwise specified
- •Patients who have tested positive for C. diff in the last 60 days
- •Patients who are hospitalized from the emergency department
- •Patients that have an oxygen saturation lower than 95% at triage
- •Altered mental status
结局指标
主要结局
Antibiotic Use
时间窗: Study Enrollment through ED Visit Discharge, up to 24 hours
The primary outcome measure is the use of antibiotics for treating acute respiratory illness.
次要结局
- Patient Confidence in Diagnosis(Study Enrollment through ED Visit Discharge, up to 24 hours)
- Utilization of Alternative Tests(Study Enrollment through ED Visit Discharge, up to 24 hours)
- Emergency Department Length of Stay(Study Enrollment through ED Visit Discharge, up to 24 hours)
- Provider Confidence in Diagnosis(Study Enrollment through ED Visit Discharge, up to 24 hours)
研究者
Christopher Payette
Assistant Professor of Emergency Medicine
George Washington University