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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT03704766
Status
Recruiting
Apply to this trial

Conditions

  • Infection of Hip Joint (Disorder)
  • Infection of Shoulder Joint
  • Joint Infection
  • Septic Arthritis

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Synovial Alpha-defensin assay — DIAGNOSTIC_TEST
    One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
  • Synovial Neutrophil elastase assay — DIAGNOSTIC_TEST
    One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
  • Synovial lactate assay — DIAGNOSTIC_TEST
    Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test.
  • Synovial C-reactive Protein (CRP) — DIAGNOSTIC_TEST
    One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
  • Synovial Staphylococcus spp antigen panel — DIAGNOSTIC_TEST
    One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
  • Synovial Candida spp antigen panel — DIAGNOSTIC_TEST
    One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
  • Synovial Enterococcus faecalis assay — DIAGNOSTIC_TEST
    One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
  • Synovial bacterial culture by BacT/Alert — DIAGNOSTIC_TEST
    The synovial fluid (joint fluid) sent to CD Diagnostics for testing will also be cultured to see if any organisms grow.
  • Synovial Cell count + differential (CBC) — DIAGNOSTIC_TEST
    One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
  • Synovial Gram Stain — DIAGNOSTIC_TEST
    This will be performed by CD Diagnostics if any organisms are present in the synovial fluid.
  • Synovial Leukocyte Esterase Test Strips — DIAGNOSTIC_TEST
    These test strips will be tested at the hospital where the patient is being seen, a few drops of synovial fluid will be used on the strip.
  • Synovial PCR for Kingella kingae — DIAGNOSTIC_TEST
    In participants \< 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR.
  • Serum Cell count + differential (CBC) — DIAGNOSTIC_TEST
    A blood test performed at the hospital.
  • Serum erythrocyte sedimentation rate (ESR) — DIAGNOSTIC_TEST
    A blood test performed at the hospital.
  • Serum C-reactive Protein (CRP) — DIAGNOSTIC_TEST
    A blood test performed at the hospital.
  • Serum D-dimer — DIAGNOSTIC_TEST
    A blood test performed at the hospital.
  • Serum Procalcitonin — DIAGNOSTIC_TEST
    A blood test performed at the hospital.
  • Blood Cultures — DIAGNOSTIC_TEST
    Blood will be cultured at the hospital to see if any organisms grow.
  • 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
    In patients with suspected inflammation/infection, there are other blood tests which may be standard of care and used for diagnosis.

Study Details

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.

Key Dates

Start date
Jun 28, 2016
Status verified
Jun 2024
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
442 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Inflamed/Infected Joint
    Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
  • Active Comparator: Normative Control
    Patient undergoing procedure unrelated to infection/inflammation

Primary Outcome Measure

Sensitivity and specificity of experimental tests [ Time Frame: Interim analysis at 2 years of study recruitment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's Healthcare of AtlantaAtlantaGeorgia30342
Jack Goldberg, MS
[email protected]
(678) 686-6864
Tim Schrader, MD
(404) 255-1933
Hospital for Special SurgeryNew YorkNew York10021
Grace Wang, BA
[email protected]
212-774-2121
Emily R Dodwell, MD, MPH
212-606-1451
Emily R Dodwell, MD, MPH (PRINCIPAL_INVESTIGATOR)
Joseph J Ruzbarsky, MD (SUB_INVESTIGATOR)
Roger F Widmann, MD (SUB_INVESTIGATOR)
Daniel W Green, MD (SUB_INVESTIGATOR)
John S Blanco, MD (SUB_INVESTIGATOR)
David M Scher, MD (SUB_INVESTIGATOR)
Shevaun M Doyle, MD (SUB_INVESTIGATOR)
Peter D Fabricant, MD, MPH (SUB_INVESTIGATOR)
Christine M Salvatore, MD (SUB_INVESTIGATOR)
Matthew Greenblatt, MD, PhD (SUB_INVESTIGATOR)
Huong Do, MS (SUB_INVESTIGATOR)
Campbell ClinicColliervilleTennessee38017
Jonathan Rowland
[email protected]
(901) 287-5413
Derek Kelly, MD
(901) 759-3100

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