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

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.

Study Overview

• Status: Completed
• Conditions: Septic Arthritis; Joint Infection

• Study Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• United States
  • California
    • Sylmar, California, United States, 91342
      • Olive View-UCLA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a prospective, multicenter, observational study being conducted at 9 EMERGEncy ID NET sites, Olive View-UCLA Medical Center, Los Angeles, CA; Temple University Hospital, Philadelphia, PA; University of Mississippi Medical Center, Jackson, MS; Valleywise Medical Center, Phoenix, AZ; Truman Medical Center/U. Missouri Kansas City, Kansas City, MO; Hennepin Medical Center, Minneapolis, MN, University of New Mexico Health Sciences Center, Albuquerque, NM; University of Iowa Hospital, Iowa City, IA; and Johns Hopkins Medical Institute, Baltimore, MD. These hospitals service a mostly urban and underserved population.

Patients presenting to the above hospital emergency departments will be approached by study team members who meet the above eligibility criteria. The target enrollment for the study is 500 participants.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of pathogens	We will describe the prevalence of pathogens identified using PCR testing	Two years
Prevalence of septic arthritis	We will describe the prevalence of septic arthritis among patients who have joint taps in emergency departments	Two years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical characteristics of septic arthritis	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	Two years
Laboratory characteristics of septic arthritis	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	Two years

Collaborators and Investigators

• Sponsor: Olive View-UCLA Education & Research Institute
• Collaborators: Centers for Disease Control and Prevention; Biofire, Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Emergencies; Arthritis; Arthritis, Infectious
• Other Study ID Numbers: 1577712

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No