Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients
Completed
Conditions studied: Septic Arthritis, Joint Infection
In brief
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.
Key facts
- Study ID
- NCT05341908
- Run by
- Olive View-UCLA Education & Research Institute
- People needed
- 750
- Starts
- 2021-09-01
- Expected to finish
- 2023-12-31
- Last updated by the study team
- 2026-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Unable to consent or no legal authorized representative is available; or
- prisoner or parolee
Where it is running
- Olive View-UCLA Medical Center — Sylmar, California, United States
Full record on ClinicalTrials.gov
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