Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients

Completed

• Conditions: Septic Arthritis; Joint Infection

• Registration Number: NCT05341908
• Lead Sponsor: Olive View-UCLA Education & Research Institute

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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-11-10
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-11
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Olive View-UCLA Medical Center; 🇺🇸 Sylmar, California, United States