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

  • STATUS
    Recruiting
  • End date
    Jun 25, 2021
  • participants needed
    442
  • sponsor
    Hospital for Special Surgery, New York
Updated on 25 January 2021

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.

Description

The purpose of this study is to determine if alpha-defensin and other proteins present in joint fluid may be able to rapidly diagnose bacterial joint infections. Patients with suspected joint infection typically undergo joint aspiration so that tests can be performed to help diagnose joint infection, including gram stain, cell count, and culture. Patients under 18 years old that are undergoing sampling of their joint fluid due to suspicion of infection or inflammation will be enrolled in this multi-center trial. Joint fluid will also be sampled from normative controls made up of patients who are undergoing an unrelated procedure without inflammation or infection. Joint fluid from patients with suspected inflammation/infection and from normative controls will be analysed for presence of alpha-defensin, leukocyte esterase, neutrophil elastase, synovial C-reactive protein, and synovial lactate. The alpha-defensin assay has shown high sensitivity and specificity for joint infection in other studies. Additionally a Staphylococcus spp antigen panel, Candida spp antigen panel, Enterococcus faecalis assay, BACTAlert culture, cell count plus differential, gram stain, and aerobic, anaerobic, and fungal cultures will be done using synovial fluid. A synovial fluid PCR for Kingella kingae will be performed if the patient is under eight years of age. Blood tests will include cell count and differential, erythrocyte sedimentation rate, C-reactive protein, procalcitonin, and D-dimer, as well as relevant inflammatory or rheumatologic marker tests. Results from these tests will be compared to joint fluid culture which the gold standard for diagnosing bacterial infection. The study includes 1 visit per patient, the standard of care visit in which the patient would be undergoing joint aspiration or arthroscopy. Once data has been collected, the sensitivity and specificity will be determined for these experimental tests both individually and in combination.

Details
Condition Pyogenic arthritis, Arthritis, Arthritis and Arthritic Pain, Joint Infection, Arthritis and Arthritic Pain (Pediatric), Infection of Hip Joint (Disorder), Infection of Shoulder Joint, Infection of Hip Joint (Disorder), Infection of Hip Joint (Disorder), Infection of Hip Joint (Disorder), infections joint, septic arthritis, Infection of Hip Joint (Disorder)
Treatment serum Procalcitonin, Synovial Alpha-defensin assay, Synovial Neutrophil elastase assay, Synovial lactate assay, Synovial C-reactive Protein (CRP), Synovial Staphylococcus spp antigen panel, Synovial Candida spp antigen panel, Synovial Enterococcus faecalis assay, Synovial bacterial culture by BacT/Alert, Synovial Cell count + differential (CBC), Synovial Gram Stain, Synovial Leukocyte Esterase Test Strips, Synovial PCR for Kingella kingae, Serum Cell count + differential (CBC), Serum erythrocyte sedimentation rate (ESR), Serum C-reactive Protein (CRP), Serum D-dimer, Blood Cultures, Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers )
Clinical Study IdentifierNCT03704766
SponsorHospital for Special Surgery, New York
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 17 yrs?
Gender: Male or Female
Do you have any of these conditions: Joint Infection or Arthritis and Arthritic Pain or Arthritis or Infection of Shoulder Joint or Infection of Hip Joint (Disorder) or Pyogenic arthritis...?
Do you have any of these conditions: Joint Infection or Pyogenic arthritis or Infection of Shoulder Joint or infections joint or septic arthritis or Infection of Hip Joint (Disorder) or A...?
Synovial fluid is obtained to assess for infection or inflammatory/rheumatologic disease (all medium and large joints will be included: hip, knee, ankle, shoulder, subtalar, elbow, and wrist joints)
Patients with recent antibiotic exposure are eligible to participate but will be analyzed separately
Inclusion Criteria- Normative Controls
Patients undergoing a procedure unrelated to infection (the procedure may be arthroscopy, or an open or percutaneous bony or soft tissue procedure)

Exclusion Criteria

Family declines to participate/consent
Patients with a major joint trauma (such as a documented ligament tear or fracture) within the past 8 weeks are not eligible to have that joint aspirated, but could have another joint aspirated
Exclusion Criteria- Normative Controls
A history of recent infection (within the past 3 months)
Received antibiotics in the past 7 days
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