A Randomized Controlled Trial of Biofire Film Array Gastrointestinal Panel Compared to Usual Care for Evaluation of Acute Infectious Diarrhea in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Number of Participants With Optimal Antibiotic Chosen
研究概览
简要总结
This research study will test a laboratory test called Film-Array Gastrointestinal (GI) Panel. This GI Panel is a test that can identify the bacteria or viruses that may cause diarrhea. This test will enable the ED doctor to better understand the cause of diarrhea to try to determine the best treatment.
The primary objective of this study is to determine if testing ED patients who complain of diarrhea will lead to more optimal use of antibiotics. Optimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Presumed infectious diarrhea (3 or more loose stools in past 24 hours)
- •Must have one of the 3 following features or symptoms lasting more than 7 days.
- •Symptoms greater than 24 hours;
- •Dehydration (defined as the need for intravenous fluid or per clinician's judgement ((based on the general appearance and alertness of the patient, the pulse, the blood pressure, the presence or absence of postural hypotension, the mucous membranes and tears, sunken eyes, skin turgor, capillary refill, and jugular venous pressure.))
- •Inflammation (defined as fever (greater than 100.1), blood in stool per patient, DRE, or tenesmus.)
排除标准
- •Chronic Symptoms (>14 days)
- •Inability to Follow- Up (i.e. no telephone)
- •Likely non-infectious cause of diarrhea (Crohn's disease, radiation colitis, irritable bowel syndrome, or celiac disease)
- •Confirmed C. Diff Diarrhea
- •Unable to provide written consent
- •Non- English speaker
结局指标
主要结局
Number of Participants With Optimal Antibiotic Chosen
时间窗: 30 Days post ED Discharge
Optimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen. Designated physicians on study staff will retrospectively examine charts of enrolled subjects will evaluate whether the antibiotic chosen by treating clinician was appropriate given GI PCR results.
次要结局
- ED Length of Stay(30 Days post ED Discharge)
- Hospital Admission Rate(30 Days post ED Discharge)
- Rate of Abdominal/Pelvic CT Scans(30 Days post ED Discharge)
研究者
Andrew Meltzer
Associate Professor of Emergency Medicine
George Washington University