Joint Infection, Septic Arthritis
Conditions
Brief 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. 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.
Interventions
None listed
Sponsors
Olive View-UCLA Education & Research Institute
BioFire Diagnostics, LLC
Centers for Disease Control and Prevention
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years and older; 2. diagnostic arthrocentesis in the emergency department (ED) or during hospitalization if admitted from the ED; 3. arthrocentesis and joint culture ordered; and 4. provide written consent in English or Spanish
Exclusion criteria
1. Unable to consent or no legal authorized representative is available; or 2. prisoner or parolee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of pathogens | Two years | We will describe the prevalence of pathogens identified using PCR testing |
| Prevalence of septic arthritis | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical characteristics of septic arthritis | 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 |
| Laboratory characteristics of septic arthritis | 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 |
Countries
United States
Outcome results
None listed