Clinical trial NCT05341908: Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients
Official title: Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients and Clinical and Laboratory Features of Patients Diagnosed With Septic Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Arthritis
Joint Infection
Lead sponsor: Olive View-UCLA Education & Research Institute
Sponsor class: OTHER
Collaborators: name: Biofire, Inc
name: Centers for Disease Control and Prevention
First posted: 2022-04-22
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of pathogens
timeFrame: Two years
measure: Prevalence of septic arthritis
timeFrame: Two years
Secondary outcomes:
measure: Clinical characteristics of septic arthritis
timeFrame: Two years
measure: Laboratory characteristics of septic arthritis
timeFrame: Two years
Other outcomes:
Locations:
city: Sylmar
country: United States
facility: Olive View-UCLA Medical Center
state: California
Study officials:
References: