Using alpha-defensin and synovial proteins to diagnose pediatric septic arthritis
Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
NA · Hospital for Special Surgery, New York · NCT03704766
This study is testing if certain proteins in joint fluid can help doctors better diagnose septic arthritis in children who might have joint infections.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 442 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York (other) |
| Locations | 3 sites (Atlanta, Georgia and 2 other locations) |
| Trial ID | NCT03704766 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the diagnosis of septic arthritis in children by evaluating the sensitivity and specificity of alpha-defensin and other synovial biomarkers in joint fluid samples. Pediatric patients under 18 years old, suspected of having joint infections, will undergo joint aspiration to collect synovial fluid for analysis. The study will compare samples from patients with suspected infections to those from normative controls undergoing unrelated procedures. Various assays will be performed on the collected fluid to identify potential biomarkers indicative of bacterial joint infections.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients under 18 years old who are undergoing joint aspiration due to suspected infection or inflammation.
Not a fit: Patients with major joint trauma within the past 8 weeks or those with a recent history of infection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnoses of septic arthritis in children, potentially reducing the need for unnecessary surgical interventions.
How similar studies have performed: Previous studies have shown that the alpha-defensin assay has high sensitivity and specificity for diagnosing joint infections, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia and 2 other locations
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (RECRUITING)
- Hospital for Special Surgery — New York, New York, United States (RECRUITING)
- Campbell Clinic — Collierville, Tennessee, United States (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Emily R Dodwell, MD, MPH — The Hospital for Special Surgery
- Study coordinator: Grace Wang, BA
- Email: wangg@hss.edu
- Phone: 212-774-2121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Joint Infection, Infection of Hip Joint, Infection of Shoulder Joint, Septic Arthritis, synovial biomarkers, alpha-defensin, diagnostics, pediatric