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NCT03704766 · ClinicalTrials.gov registry record · NA
Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
A NA study of Joint Infection and Septic Arthritis, sponsored by Hospital for Special Surgery, New York.
- Recruiting
- Registry status
- NA
- Development phase
- 442
- Enrollment target
- 3
- Study locations
NCT03704766: Recruiting NA study of Joint Infection and Septic Arthritis, sponsored by Hospital for Special Surgery, New York.
NCT03704766 is a NA study of Joint Infection and Septic Arthritis that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 442 participants, above the 346-participant average among 6 other Joint Infection trials with a reported enrollment target (28% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03704766, a NA study of Joint Infection and Septic Arthritis, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.
- RECRUITING
- Registry status
- NA
- Development phase
- 442 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Primary Outcome
Sensitivity and specificity have been selected as these are standard outcome tests when determining the utility of a diagnostic test.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST 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
Study Locations (3)
Georgia
- Children's Healthcare of Atlanta - Atlanta
New York
- Hospital for Special Surgery - New York
Tennessee
- Campbell Clinic - Collierville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 442 participants |
| Start Date | 2016-06-28 |
| Est. Completion | 2026-05 |
| Phase | NA |
What NCT03704766 shows while recruiting
NCT03704766 is an interventional study that assigns participants to a tested intervention. The registered 442 participants enrollment target is mid-sized for trials with a published cap, above the 346-participant average among 6 other Joint Infection trials with a reported enrollment target (28% higher).
The record links to 4 conditions, with Joint Infection appearing as the primary indexed condition, and to 5 interventions - of which Synovial Alpha-defensin assay is the first listed.
NCT03704766 reports a single indexed study location in Georgia, New York, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03704766 about?
NCT03704766 is a clinical study titled "Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis". 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 childre...
What is the current status of trial NCT03704766?
This trial is currently recruiting. It is a NA study. The enrollment target is 442 participants. The study started on 2016-06-28. Estimated completion is 2026-05.
What conditions does trial NCT03704766 study?
This clinical trial studies the following conditions: Joint Infection, Septic Arthritis, Infection of Hip Joint (Disorder), Infection of Shoulder Joint.
What interventions are being tested in trial NCT03704766?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT03704766?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03704766 being conducted?
This trial has 3 study locations across Georgia, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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