Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients

NCT05341908 | Completed

• 1 other identifier: 1577712
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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. 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. 2.Describe the epidemiology of patients receiving diagnostic arthrocentesis and those diagnosed with septic arthritis in the emergency department (ED),
3. 3.Determine the prevalence of septic arthritis in US ED patients presenting with an atraumatic painful swollen joint, and
4. 4.Determine the clinical (history and physical examination) and laboratory characteristics of septic arthritis.

Conditions

Septic Arthritis; Joint Infection

Outcome Measures

Primary Outcomes (2)

• Prevalence of pathogens

  We will describe the prevalence of pathogens identified using PCR testing

  Two years

• Prevalence of septic arthritis

  We will describe the prevalence of septic arthritis among patients who have joint taps in emergency departments

  Two years

Secondary Outcomes (2)

• Clinical characteristics of septic arthritis

  Two years

• Laboratory characteristics of septic arthritis

  Two years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Olive View-UCLA Education & Research Institute: lead
• Biofire, Inc: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Olive View-UCLA Medical Center

Sylmar, California, 91342, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Synovial fluid

MeSH Terms

Conditions

Arthritis, Infectious

Condition Hierarchy (Ancestors)

Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: April 22, 2022
• Study Start: September 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 13, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)