Septic ArthritisNCT05341908
Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients
An observational study of Septic Arthritis and Joint Infection, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
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.… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Arthritis, Joint Infection
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Unable to consent or no legal authorized representative is available; or
- prisoner or parolee
Trial locations and contacts
1 site in 1 country.
United States1 site
Olive View-UCLA Medical Center
Sylmar, California, 91342
About this study
Official title: Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients and Clinical and Laboratory Features of Patients Diagnosed With Septic Arthritis
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:
- 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,
- Describe the epidemiology of patients receiving diagnostic arthrocentesis and those diagnosed with septic arthritis in the emergency department (ED),
- Determine the prevalence of septic arthritis in US ED patients presenting with an atraumatic painful swollen joint, and
- Determine the clinical (history and physical examination) and laboratory characteristics of septic arthritis.
- 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.
- Conditions
- Septic Arthritis, Joint Infection
- Medical subject headings
- Arthritis, Infectious
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of pathogens
We will describe the prevalence of pathogens identified using PCR testing
Measured: Two years
Prevalence of septic arthritis
We will describe the prevalence of septic arthritis among patients who have joint taps in emergency departments
Measured: Two years
Comparison of PCR and Synovial fluid culture results
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.
Measured: Results of testing synovial fluid specimen collected at enrollment
Secondary outcomes (2)
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
Measured: Two years
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
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Sep 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olive View-UCLA Education & Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- BioFire Diagnostics, LLC, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, David A. Talan, Olive View-UCLA Education & Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341908
- Sponsor's protocol ID
- 1577712
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steele MT, Stubbs AM, Krishnadasan A, Kemble L, Li R, Mower WR, Liao J, Moran GJ, Talan DA; (co-senior authors) for the EMERGEncy ID NET Study Group. Performance and Projected Impact of Synovial Fluid Polymerase Chain Reaction Testing for Patients Evaluated for Septic Arthritis. Clin Infect Dis. 2026 Aug 31:ciag476. doi: 10.1093/cid/ciag476. Online ahead of print.
PubMed 42671259
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Pathogens in Synovial Fluid Obtained From Emergency Department Patients and Clinical and Laboratory Features of Patients Diagnosed With Septic Arthritis
- ClinicalTrials.gov ID
- NCT05341908
- Acronym / sponsor ID
- 1577712
- Conditions
- Septic Arthritis, Joint Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Olive View-UCLA Education & Research InstituteUniversity, hospital or other
- Collaborators
- BioFire Diagnostics, LLC, Centers for Disease Control and Prevention
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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,
- Describe the epidemiology of patients receiving diagnostic arthrocentesis and those diagnosed with septic arthritis in the emergency department (ED),
- Determine the prevalence of septic arthritis in US ED patients presenting with an atraumatic painful swollen joint, and
- Determine the clinical (history and physical examination) and laboratory characteristics of septic arthritis.
- 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
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to consent or no legal authorized representative is available; or
- prisoner or parolee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Clinical characteristics of septic arthritis
Time frame: Two years
Laboratory characteristics of septic arthritis
Time frame: Two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Derived from this study: PubMed 42671259Steele MT, Stubbs AM, Krishnadasan A, Kemble L, Li R, Mower WR, Liao J, Moran GJ, Talan DA; (co-senior authors) for the EMERGEncy ID NET Study Group. Performance and Projected Impact of Synovial Fluid Polymerase Chain Reaction Testing for Patients Evaluated for Septic Arthritis. Clin Infect Dis. 2026 Aug 31:ciag476. doi: 10.1093/cid/ciag476. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Arthritis and Joint Infection, run by Olive View-UCLA Education & Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of pathogens (time frame: Two years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05341908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.