Diagnostic Tests for Pediatric Septic Arthritis
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, patients with recent antibiotic exposure can participate, but they will be analyzed separately.
What data supports the effectiveness of the treatment Alpha-defensin assay, Alpha-defensin test, Alpha-defensin lateral flow assay, Synovasure for diagnosing pediatric septic arthritis?
The Alpha-defensin lateral flow test, known as Synovasure, has been shown to quickly and accurately diagnose infections in joint fluid, particularly in cases of prosthetic joint infections, even when antibiotics are present. While its effectiveness for pediatric septic arthritis specifically isn't directly studied, its success in similar joint infection scenarios suggests it could be a useful diagnostic tool.12345
Is the Alpha-defensin test safe for humans?
How does the alpha-defensin test differ from other treatments for pediatric septic arthritis?
What is the purpose of this trial?
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.
Research Team
Emily R Dodwell, MD, MPH
Principal Investigator
The Hospital for Special Surgery
Eligibility Criteria
This trial is for children with joint inflammation who are undergoing procedures to assess for infection or inflammatory diseases. It includes those with recent antibiotic use, covering various joints like the hip, knee, and shoulder. Children not being assessed for infection-related procedures are excluded.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Standard of Care Visit
Participants undergo joint aspiration or arthroscopy for diagnostic testing
Follow-up
Participants are monitored for safety and effectiveness after diagnostic procedures
Treatment Details
Interventions
- Alpha-defensin assay
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hospital for Special Surgery, New York
Lead Sponsor
Campbell Clinic
Collaborator
Pediatric Orthopaedic Society of North America
Collaborator
Children's Healthcare of Atlanta
Collaborator
CD Diagnostics
Industry Sponsor