Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis (NCT03704766)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Healthcare of Atlanta — Atlanta, Georgia
Age range: Not specified to 17 Years
🧪 Interventions in This Study
- Synovial Alpha-defensin assay (DIAGNOSTIC_TEST)
- Synovial Neutrophil elastase assay (DIAGNOSTIC_TEST)
- Synovial lactate assay (DIAGNOSTIC_TEST)
- Synovial C-reactive Protein (CRP) (DIAGNOSTIC_TEST)
- Synovial Staphylococcus spp antigen panel (DIAGNOSTIC_TEST)
- Synovial Candida spp antigen panel (DIAGNOSTIC_TEST)
- Synovial Enterococcus faecalis assay (DIAGNOSTIC_TEST)
- Synovial bacterial culture by BacT/Alert (DIAGNOSTIC_TEST)
- Synovial Cell count + differential (CBC) (DIAGNOSTIC_TEST)
- Synovial Gram Stain (DIAGNOSTIC_TEST)
- Synovial Leukocyte Esterase Test Strips (DIAGNOSTIC_TEST)
- Synovial PCR for Kingella kingae (DIAGNOSTIC_TEST)
- Serum Cell count + differential (CBC) (DIAGNOSTIC_TEST)
- Serum erythrocyte sedimentation rate (ESR) (DIAGNOSTIC_TEST)
- Serum C-reactive Protein (CRP) (DIAGNOSTIC_TEST)
- Serum D-dimer (DIAGNOSTIC_TEST)
- Serum Procalcitonin (DIAGNOSTIC_TEST)
- Blood Cultures (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 ) (DIAGNOSTIC_TEST)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- Children's Healthcare of Atlanta — Atlanta, Georgia
- Hospital for Special Surgery — New York, New York
- Campbell Clinic — Collierville, Tennessee
📞 Contact the Study Coordinator
Phone: (212) 774-2121
Email: wangg@hss.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.