Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
- Conditions
- Joint InfectionSeptic ArthritisInfection of Shoulder JointInfection of Hip Joint (Disorder)
- Interventions
- Diagnostic Test: Synovial Alpha-defensin assayDiagnostic Test: Synovial Neutrophil elastase assayDiagnostic Test: Synovial lactate assayDiagnostic Test: Synovial C-reactive Protein (CRP)Diagnostic Test: Synovial Staphylococcus spp antigen panelDiagnostic Test: Synovial Candida spp antigen panelDiagnostic Test: Synovial Enterococcus faecalis assayDiagnostic Test: Synovial bacterial culture by BacT/AlertDiagnostic Test: Synovial Cell count + differential (CBC)Diagnostic Test: Synovial Gram StainDiagnostic Test: Synovial Leukocyte Esterase Test StripsDiagnostic Test: Synovial PCR for Kingella kingaeDiagnostic Test: Serum Cell count + differential (CBC)Diagnostic Test: Serum erythrocyte sedimentation rate (ESR)Diagnostic Test: Serum C-reactive Protein (CRP)Diagnostic Test: Serum D-dimerDiagnostic Test: Serum ProcalcitoninDiagnostic Test: Blood CulturesDiagnostic Test: Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers )
- Registration Number
- NCT03704766
- Lead Sponsor
- Hospital for Special Surgery, New York
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 442
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normative Control Serum D-dimer Patient undergoing procedure unrelated to infection/inflammation Inflamed/Infected Joint Synovial lactate assay Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Synovial Staphylococcus spp antigen panel Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Synovial Leukocyte Esterase Test Strips Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Synovial bacterial culture by BacT/Alert Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Synovial Cell count + differential (CBC) Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Synovial Gram Stain Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Synovial Neutrophil elastase assay Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Synovial C-reactive Protein (CRP) Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Synovial Candida spp antigen panel Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Normative Control Synovial Gram Stain Patient undergoing procedure unrelated to infection/inflammation Inflamed/Infected Joint Synovial Alpha-defensin assay Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Synovial Enterococcus faecalis assay Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Serum D-dimer Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Normative Control Synovial Neutrophil elastase assay Patient undergoing procedure unrelated to infection/inflammation Normative Control Synovial C-reactive Protein (CRP) Patient undergoing procedure unrelated to infection/inflammation Normative Control Synovial bacterial culture by BacT/Alert Patient undergoing procedure unrelated to infection/inflammation Inflamed/Infected Joint Serum erythrocyte sedimentation rate (ESR) Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Serum Procalcitonin Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Normative Control Synovial Staphylococcus spp antigen panel Patient undergoing procedure unrelated to infection/inflammation Normative Control Synovial Enterococcus faecalis assay Patient undergoing procedure unrelated to infection/inflammation Normative Control Serum Cell count + differential (CBC) Patient undergoing procedure unrelated to infection/inflammation Inflamed/Infected Joint Synovial PCR for Kingella kingae Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Normative Control Synovial Alpha-defensin assay Patient undergoing procedure unrelated to infection/inflammation Normative Control Serum Procalcitonin Patient undergoing procedure unrelated to infection/inflammation Normative Control Blood Cultures Patient undergoing procedure unrelated to infection/inflammation Inflamed/Infected Joint Serum C-reactive Protein (CRP) Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Blood Cultures Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Normative Control Synovial Leukocyte Esterase Test Strips Patient undergoing procedure unrelated to infection/inflammation Normative Control Synovial PCR for Kingella kingae Patient undergoing procedure unrelated to infection/inflammation Normative Control Serum erythrocyte sedimentation rate (ESR) Patient undergoing procedure unrelated to infection/inflammation Normative Control Serum C-reactive Protein (CRP) Patient undergoing procedure unrelated to infection/inflammation Inflamed/Infected Joint Serum Cell count + differential (CBC) Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Inflamed/Infected Joint Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers ) Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition Normative Control Synovial lactate assay Patient undergoing procedure unrelated to infection/inflammation Normative Control Synovial Candida spp antigen panel Patient undergoing procedure unrelated to infection/inflammation Normative Control Synovial Cell count + differential (CBC) Patient undergoing procedure unrelated to infection/inflammation Normative Control Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers ) Patient undergoing procedure unrelated to infection/inflammation
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of experimental tests Interim analysis at 2 years of study recruitment Sensitivity and specificity have been selected as these are standard outcome tests when determining the utility of a diagnostic test.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Campbell Clinic
🇺🇸Collierville, Tennessee, United States