Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis

June 17, 2025 updated by: Hospital for Special Surgery, New York
Differentiating between septic arthritis and other causes of joint inflammation in pediatric patients is challenging and of the utmost importance because septic arthritis requires surgical debridement as part of the treatment regimen. The current gold standard to diagnose septic arthritis in children is a positive synovial fluid culture; however, joint cultures may take several days to return. If a bacterial infection is present, it requires immediate surgical intervention in order to prevent lasting articular cartilage damage. Frequently surgeons must decide whether to surgically debride a joint before culture results are available. There is no single lab test or clinical feature that reliably indicates bacterial infection over other causes of joint inflammation. The alpha-defensin assay has shown high sensitivity and specificity for joint infection in other studies.The purpose of this study is to determine the sensitivity and specificity of several synovial biomarkers for diagnosing pediatric septic arthritis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study is to determine if alpha-defensin and other proteins present in joint fluid may be able to rapidly diagnose bacterial joint infections. Patients with suspected joint infection typically undergo joint aspiration so that tests can be performed to help diagnose joint infection, including gram stain, cell count, and culture. Patients under 18 years old that are undergoing sampling of their joint fluid due to suspicion of infection or inflammation will be enrolled in this multi-center trial. Joint fluid will also be sampled from normative controls made up of patients who are undergoing an unrelated procedure without inflammation or infection. Joint fluid from patients with suspected inflammation/infection and from normative controls will be analysed for presence of alpha-defensin, leukocyte esterase, neutrophil elastase, synovial C-reactive protein, and synovial lactate. The alpha-defensin assay has shown high sensitivity and specificity for joint infection in other studies. Additionally a Staphylococcus spp antigen panel, Candida spp antigen panel, Enterococcus faecalis assay, BACTAlert culture, cell count plus differential, gram stain, and aerobic, anaerobic, and fungal cultures will be done using synovial fluid. A synovial fluid PCR for Kingella kingae will be performed if the patient is under eight years of age. Blood tests will include cell count and differential, erythrocyte sedimentation rate, C-reactive protein, procalcitonin, and D-dimer, as well as relevant inflammatory or rheumatologic marker tests. Results from these tests will be compared to joint fluid culture which the gold standard for diagnosing bacterial infection. The study includes 1 visit per patient, the standard of care visit in which the patient would be undergoing joint aspiration or arthroscopy. Once data has been collected, the sensitivity and specificity will be determined for these experimental tests both individually and in combination.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
442

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Grace Wang, BA
  • Phone Number: 212-774-2121
  • Email: wangg@hss.edu

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Children's Healthcare of Atlanta
        • Contact:
          • Tim Schrader, MD
          • Phone Number: (404) 255-1933
        • Contact:
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Hospital for Special Surgery
        • Sub-Investigator:
          • Huong Do, MS
        • Sub-Investigator:
          • Roger F Widmann, MD
        • Contact:
        • Contact:
          • Emily R Dodwell, MD, MPH
          • Phone Number: 212-606-1451
        • Principal Investigator:
          • Emily R Dodwell, MD, MPH
        • Sub-Investigator:
          • Joseph J Ruzbarsky, MD
        • Sub-Investigator:
          • Peter D Fabricant, MD, MPH
        • Sub-Investigator:
          • Christine M Salvatore, MD
        • Sub-Investigator:
          • Matthew Greenblatt, MD, PhD
        • Sub-Investigator:
          • Daniel W Green, MD
        • Sub-Investigator:
          • John S Blanco, MD
        • Sub-Investigator:
          • David M Scher, MD
        • Sub-Investigator:
          • Shevaun M Doyle, MD
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Not yet recruiting
        • Campbell Clinic
        • Contact:
          • Derek Kelly, MD
          • Phone Number: (901) 759-3100
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 13 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria- Septic Cases and Inflamed, Non-Septic Comparators:

  • Synovial fluid is obtained to assess for infection or inflammatory/rheumatologic disease (all medium and large joints will be included: hip, knee, ankle, shoulder, subtalar, elbow, and wrist joints)
  • Patients with recent antibiotic exposure are eligible to participate but will be analyzed separately

Inclusion Criteria- Normative Controls:

  • Patients undergoing a procedure unrelated to infection (the procedure may be arthroscopy, or an open or percutaneous bony or soft tissue procedure)

Exclusion Criteria- All Participants:

  • Family declines to participate/consent
  • Patients with a major joint trauma (such as a documented ligament tear or fracture) within the past 8 weeks are not eligible to have that joint aspirated, but could have another joint aspirated

Exclusion Criteria- Normative Controls:

  • A history of recent infection (within the past 3 months)
  • Received antibiotics in the past 7 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
Diagnostic test: Synovial Alpha-defensin assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial Neutrophil elastase assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial lactate assay
Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test.
Diagnostic test: Synovial C-reactive Protein (CRP)
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial Staphylococcus spp antigen panel
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial Candida spp antigen panel
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial Enterococcus faecalis assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial bacterial culture by BacT/Alert
The synovial fluid (joint fluid) sent to CD Diagnostics for testing will also be cultured to see if any organisms grow.
Diagnostic test: Synovial Cell count + differential (CBC)
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial Gram Stain
This will be performed by CD Diagnostics if any organisms are present in the synovial fluid.
Diagnostic test: Synovial Leukocyte Esterase Test Strips
These test strips will be tested at the hospital where the patient is being seen, a few drops of synovial fluid will be used on the strip.
Diagnostic test: Synovial PCR for Kingella kingae
In participants < 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR.
Diagnostic test: Serum Cell count + differential (CBC)
A blood test performed at the hospital.
Diagnostic test: Serum erythrocyte sedimentation rate (ESR)
A blood test performed at the hospital.
Diagnostic test: Serum C-reactive Protein (CRP)
A blood test performed at the hospital.
Diagnostic test: Serum D-dimer
A blood test performed at the hospital.
Diagnostic test: Serum Procalcitonin
A blood test performed at the hospital.
Diagnostic test: Blood Cultures
Blood will be cultured at the hospital to see if any organisms grow.
Diagnostic test: Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers )
In patients with suspected inflammation/infection, there are other blood tests which may be standard of care and used for diagnosis.
Active Comparator: Normative Control
Patient undergoing procedure unrelated to infection/inflammation
Diagnostic test: Synovial Alpha-defensin assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial Neutrophil elastase assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial lactate assay
Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test.
Diagnostic test: Synovial C-reactive Protein (CRP)
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial Staphylococcus spp antigen panel
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial Candida spp antigen panel
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial Enterococcus faecalis assay
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial bacterial culture by BacT/Alert
The synovial fluid (joint fluid) sent to CD Diagnostics for testing will also be cultured to see if any organisms grow.
Diagnostic test: Synovial Cell count + differential (CBC)
One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
Diagnostic test: Synovial Gram Stain
This will be performed by CD Diagnostics if any organisms are present in the synovial fluid.
Diagnostic test: Synovial Leukocyte Esterase Test Strips
These test strips will be tested at the hospital where the patient is being seen, a few drops of synovial fluid will be used on the strip.
Diagnostic test: Synovial PCR for Kingella kingae
In participants < 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR.
Diagnostic test: Serum Cell count + differential (CBC)
A blood test performed at the hospital.
Diagnostic test: Serum erythrocyte sedimentation rate (ESR)
A blood test performed at the hospital.
Diagnostic test: Serum C-reactive Protein (CRP)
A blood test performed at the hospital.
Diagnostic test: Serum D-dimer
A blood test performed at the hospital.
Diagnostic test: Serum Procalcitonin
A blood test performed at the hospital.
Diagnostic test: Blood Cultures
Blood will be cultured at the hospital to see if any organisms grow.
Diagnostic test: Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers )
In patients with suspected inflammation/infection, there are other blood tests which may be standard of care and used for diagnosis.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of experimental tests
Time Frame: Interim analysis at 2 years of study recruitment
Sensitivity and specificity have been selected as these are standard outcome tests when determining the utility of a diagnostic test.
Interim analysis at 2 years of study recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital for Special Surgery, New York

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Healthcare of Atlanta
Campbell Clinic
Pediatric Orthopaedic Society of North America
CD Diagnostics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily R Dodwell, MD, MPH, The Hospital for Special Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015-947

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Collaborating sites will share de-identified patient data with the primary site, the Hospital for Special Surgery. The Hospital for Special Surgery, will incorporate de-identified aggregated data into a separate de-identified aggregated data sat to be provided to all study sites, but individual participant data will not be shared with all sites.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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