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Completed

NCT Number: NCT05341908

Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Prevalence of pathogens

    Time frame: Two years

    We will describe the prevalence of pathogens identified using PCR testing

  2. 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

  3. 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

  1. Clinical characteristics of septic arthritis

    Time frame: 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

  2. Laboratory characteristics of septic arthritis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Olive View-UCLA Education & Research Institute

Other

Collaborators

  • BioFire Diagnostics, LLC
  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2022
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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