跳至主要内容
临床试验/NCT02957136
NCT02957136已完成不适用

Randomized Clinical Trial of Multi-respiratory Pathogen Testing Versus Usual Care in Emergency Department (ED) Patients With Upper Respiratory Symptoms

University of California, Davis2 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2016年12月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
194
试验地点
2
主要终点
Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED

研究概览

简要总结

This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI).

详细描述

This is a randomized clinical trial to assess the effect of rapid, near point-of-care testing for multiple common respiratory viruses and bacteria on antibiotic and anti-influenza medication use in emergency department (ED) patients with symptoms of influenza-like illness (ILI) and/or upper respiratory infection (URI). The intervention is a rapid, multi-respiratory pathogen nucleic acid amplification panel test (FilmArray Respiratory Panel; BioFire Diagnostics, LLC) with clinical result reporting within two hours of sample collection. Randomization is at the individual patient level. Intervention patients will receive usual care plus the rapid multi-respiratory pathogen test. Control patients will receive physician-directed usual care without the rapid, multi-respiratory pathogen test, which may include but is not limited to no testing, point-of-care influenza testing, or delayed testing for multiple respiratory pathogens at an off-site laboratory. The primary outcome is antibiotic administration or prescription during the initial ED episode of care. The investigators primary hypothesis is that rapid multi-respiratory pathogen testing will be associated with a ≥15% reduction in antibiotic use in intervention patients, relative to control patients (usual care). The investigators secondary outcome is administration or prescription of antivirals during the initial ED episode of care. The investigators secondary hypothesis is that rapid multi-respiratory pathogen testing will improve anti-influenza medication use in intervention patients (composite rate of anti-influenza treatment in positive patients and non-use of anti-influenza treatment in negative patients), relative to control patients receiving usual care alone.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
1 Year 至 101 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • University of California, Davis (UC Davis) Emergency Department patients evaluated for influenza like illness and/or upper respiratory infection by an ED physician who consent and agree to have a nasopharyngeal swab collected for the study
  • English speaking or Spanish speaking patients

排除标准

  • Prisoners
  • Employees of UC Davis/Students of the Principal Investigator or Co-Principal Investigator
  • Non-English, non-Spanish speaking patients

结局指标

主要结局

Proportion of Patients Receiving Antibiotics or a Prescription for Antibiotics in the ED

时间窗: Day 0

次要结局

  • Proportion of Patients With a Respiratory Pathogen Identified(Day 0)
  • Proportion of Patients With a Laboratory-confirmed Influenza Diagnosis(Day 0)
  • Proportion of Patients Receiving Appropriate Anti-influenza Treatment or Prescription(Day 0)
  • Proportion of Patients Discharged Home From the ED Versus Hospital Admission(Day 0)
  • Proportion of Patients With All-cause or Respiratory Illness-related Repeat ED Visit, Hospital or ICU Admission, or Death Within 30 Days(30 days)
  • Proportion of of Patients With Clinician Adherence to Guidelines for the Treatment of Patients With Influenza (Recommendations for Use of Antivirals Only)(Day 0)
  • Median Length of ED Stay(Day 0)
  • Median Length of Hospital Stay(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验