Olive View-UCLA Medical Center
Sylmar, California, 91342, United States
NCT Number: NCT05341908
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.
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Notify Me18 year and older
All sexes
Observational
Sylmar, California, 91342, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Two years
We will describe the prevalence of pathogens identified using PCR testing
Time frame: Two years
We will describe the prevalence of septic arthritis among patients who have joint taps in emergency departments
Time frame: 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.
Time frame: Two years
We will compare clinical characteristics, such as duration of symptoms, medical history, immunocompromising conditions, vitals, and demographics between those who have septic arthritis vs. those who do not to determine if there are possible predictors
Time frame: Two years
We will compare laboratory characteristics, such as white blood cell count, presence of crystals, gram stain, and culture results between those who have septic arthritis vs. those who do not to determine if there are possible predictors
Olive View-UCLA Education & Research Institute
Other
Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients and Clinical and Laboratory Features of Patients Diagnosed With Septic Arthritis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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