Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients

Septic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05341908
• Other study ID #: 1577712
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2024
• Source: Olive View-UCLA Education & Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Infectious
• Emergencies
• Joint Infection
• Septic Arthritis

Locations

Country	Name	City	State
United States	Olive View-UCLA Medical Center	Sylmar	California

Sponsors (3)

Lead Sponsor	Collaborator
Olive View-UCLA Education & Research Institute	Biofire, Inc, Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of pathogens	We will describe the prevalence of pathogens identified using PCR testing	Two years
Primary	Prevalence of septic arthritis	We will describe the prevalence of septic arthritis among patients who have joint taps in emergency departments	Two years
Secondary	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
Secondary	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