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Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: May 2026 to Nov 2026
    • Study completion date: May 2026 to Jan 2027
    v9
  2. Primary and study completion dates: May 2025 to May 2026
    • Site contacts updated at 2 of 3 sites
    v8
  3. Primary and study completion dates: May 2024 to May 2025v7
  4. Primary and study completion dates: Jun 2023 to May 2024v6
  5. Primary and study completion dates: Jun 2022 to Jun 2023v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary and study completion dates: Jun 2021 to Jun 2022v4
  2. Primary completion date: May 2020 to Jun 2021
    • Study completion date: Jul 2020 to Jun 2021
    v3
  3. Start date: Jul 15, 2016 to Jun 28, 2016v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03704766
Lead Sponsor Hospital for Special Surgery, New York
Collaborators: Pediatric Orthopaedic Society of North America, Children's Healthcare of Atlanta, Campbell Clinic, CD Diagnostics
Conditions
(from sponsor)		 Joint Infection, Infection of Hip Joint (Disorder), Infection of Shoulder Joint, Septic Arthritis
Related terms Arthritis, Infectious
Enrollment 442 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov