Trials / Recruiting
RecruitingNCT03704766
Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 442 (estimated)
- Sponsor
- Hospital for Special Surgery, New York · Academic / Other
- Sex
- All
- Age
- 17 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Synovial Alpha-defensin assay | One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics. |
| DIAGNOSTIC_TEST | Synovial Neutrophil elastase assay | One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics. |
| DIAGNOSTIC_TEST | Synovial lactate assay | Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test. |
| DIAGNOSTIC_TEST | Synovial C-reactive Protein (CRP) | One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics. |
| DIAGNOSTIC_TEST | Synovial Staphylococcus spp antigen panel | One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics. |
| DIAGNOSTIC_TEST | Synovial Candida spp antigen panel | One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics. |
| DIAGNOSTIC_TEST | Synovial Enterococcus faecalis assay | One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics. |
| DIAGNOSTIC_TEST | Synovial bacterial culture by BacT/Alert | The synovial fluid (joint fluid) sent to CD Diagnostics for testing will also be cultured to see if any organisms grow. |
| DIAGNOSTIC_TEST | Synovial Cell count + differential (CBC) | One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics. |
| DIAGNOSTIC_TEST | Synovial Gram Stain | This will be performed by CD Diagnostics if any organisms are present in the synovial fluid. |
| DIAGNOSTIC_TEST | Synovial Leukocyte Esterase Test Strips | 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. |
| DIAGNOSTIC_TEST | Synovial PCR for Kingella kingae | In participants \< 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR. |
| DIAGNOSTIC_TEST | Serum Cell count + differential (CBC) | A blood test performed at the hospital. |
| DIAGNOSTIC_TEST | Serum erythrocyte sedimentation rate (ESR) | A blood test performed at the hospital. |
| DIAGNOSTIC_TEST | Serum C-reactive Protein (CRP) | A blood test performed at the hospital. |
| DIAGNOSTIC_TEST | Serum D-dimer | A blood test performed at the hospital. |
| DIAGNOSTIC_TEST | Serum Procalcitonin | A blood test performed at the hospital. |
| DIAGNOSTIC_TEST | Blood Cultures | Blood will be cultured at the hospital to see if any organisms grow. |
| DIAGNOSTIC_TEST | Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers ) | In patients with suspected inflammation/infection, there are other blood tests which may be standard of care and used for diagnosis. |
Timeline
- Start date
- 2016-06-28
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2018-10-15
- Last updated
- 2025-06-22
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03704766. Inclusion in this directory is not an endorsement.