Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    500
  • sponsor
    Olive View-UCLA Education & Research Institute
Updated on 30 April 2022

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.

Details
Condition Septic Arthritis, Joint Infection
Clinical Study IdentifierNCT05341908
SponsorOlive View-UCLA Education & Research Institute
Last Modified on30 April 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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