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Clinical Trials/NCT05341908
NCT05341908CompletedNot Applicable

Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients and Clinical and Laboratory Features of Patients Diagnosed With Septic Arthritis

Olive View-UCLA Education & Research Institute1 site in 1 country750 target enrollmentStarted: September 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
750
Locations
1
Primary Endpoint
Prevalence of pathogens

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age 18 years and older;
  • •diagnostic arthrocentesis in the emergency department (ED) or during hospitalization if admitted from the ED;
  • •arthrocentesis and joint culture ordered; and
  • •provide written consent in English or Spanish

Exclusion Criteria

  • •Unable to consent or no legal authorized representative is available; or
  • •prisoner or parolee

Outcomes

Primary Outcomes

Prevalence of pathogens

Time Frame: Two years

We will describe the prevalence of pathogens identified using PCR testing

Prevalence of septic arthritis

Time Frame: 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

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.

Secondary Outcomes

  • Laboratory characteristics of septic arthritis(Two years)
  • Clinical characteristics of septic arthritis(Two years)

Investigators

Sponsor
Olive View-UCLA Education & Research Institute
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David A. Talan

Professor of Medicine

Olive View-UCLA Education & Research Institute

Study Sites (1)

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