NCT05341908

Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 750 (actual)
• Sponsor: Olive View-UCLA Education & Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. 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.

Conditions

• Septic Arthritis
• Joint Infection

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-04-22
• Last updated: 2024-06-13

Locations

1 site across 1 country: United States