跳至主要内容
临床试验/NCT05341908
NCT05341908已完成不适用

Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients and Clinical and Laboratory Features of Patients Diagnosed With Septic Arthritis

Olive View-UCLA Education & Research Institute1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
750
试验地点
1
主要终点
Prevalence of pathogens

研究概览

简要总结

This is a prospective, observational study of patients presenting to the emergency departments at 9 EMERGEncy ID NET sites. The objectives of the proposed study are to:

  1. Describe the range and proportion of infectious agents in synovial fluid as detected by standard C&S and investigational PCR testing, i.e., Biofire® Film Array® Bone and Joint Infection (BJI) Panel,
  2. Describe the epidemiology of patients receiving diagnostic arthrocentesis and those diagnosed with septic arthritis in the emergency department (ED),
  3. Determine the prevalence of septic arthritis in US ED patients presenting with an atraumatic painful swollen joint, and
  4. Determine the clinical (history and physical examination) and laboratory characteristics of septic arthritis.
  5. Determine the performance characteristics and concordance of synovial fluid PCR compared to culture, and project the impact of point-of-care PCR on patient management.

Study coordinators screen the ED log for adult patients presenting with joint pain and whose treating physician ordered an arthrocentesis. After confirming eligibility, study coordinators approach the patient to explain the study, and present the written consent form. If the patient agrees to participate and consent, the study coordinator completes an enrollment data collection using patient and treating physician interview to gather responses. After enrollment, the study coordinator will ensure that approximately 0.3-1.0 mL of leftover synovial fluid is saved and stored in a freezer for shipment to a central laboratory (Truman Medical Center hospital laboratory, Kansas City, MO) for testing. Approximately 30 days after enrollment, study coordinators complete an electronic medical record (EMR) review.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
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

  • •Age 18 years and older;
  • •diagnostic arthrocentesis in the emergency department (ED) or during hospitalization if admitted from the ED;
  • •arthrocentesis and joint culture ordered; and
  • •provide written consent in English or Spanish

排除标准

  • •Unable to consent or no legal authorized representative is available; or
  • •prisoner or parolee

结局指标

主要结局

Prevalence of pathogens

时间窗: Two years

We will describe the prevalence of pathogens identified using PCR testing

Prevalence of septic arthritis

时间窗: Two years

We will describe the prevalence of septic arthritis among patients who have joint taps in emergency departments

Comparison of PCR and Synovial fluid culture results

时间窗: Results of testing synovial fluid specimen collected at enrollment

The results of the PCR testing will be compared to the results of testing at the site hospital laboratories. PCR positive patients that were not standard culture positive will be further reviewed to determine if there would potentially have been a change in patient management knowing this information.

次要结局

  • Laboratory characteristics of septic arthritis(Two years)
  • Clinical characteristics of septic arthritis(Two years)

研究者

发起方
Olive View-UCLA Education & Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

David A. Talan

Professor of Medicine

Olive View-UCLA Education & Research Institute

研究点 (1)

Loading locations...

相似试验