Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
Public ClinicalTrials.gov record NCT03704766. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT03704766
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 442 participants
Conditions and interventions
Conditions
Interventions
- 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
Diagnostic Test
Eligibility (public fields only)
- Age range
- Up to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 27, 2016
- Primary completion
- Oct 31, 2026
- Completion
- Dec 31, 2026
- Last update posted
- Jul 28, 2026
2016 – 2027
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30342 | Recruiting |
| Hospital for Special Surgery | New York | New York | 10021 | Recruiting |
| Campbell Clinic | Collierville | Tennessee | 38017 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03704766, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03704766 live on ClinicalTrials.gov.