Alpha-Defensin and Synovial Proteins to Improve Detection of Pediatric Septic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 442
- 试验地点
- 3
- 主要终点
- Sensitivity and specificity of experimental tests
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
盲法说明
For patients with inflamed joints, the medical team will be blind to the results of the alpha-defensin assay and other experimental tests for a period of 2 weeks, after which results may be divulged to the clinical team at their request. As such, the results will not influence the physician/surgeons' decision for acute treatment of the patient, as the decision to treat suspected septic arthritis is typically made within 24 hours, and the final diagnosis is made within 2 weeks (pending culture results). As the testing of the leukocyte esterase strips will occur in the operating room, the surgeon will not be blinded to these results. A blinded team member will read the pictures of all of the leukocyte test strip results at once, after they have all been collected. The patient will be made aware of results at the physician/surgeon's discretion. For normative controls, the results of experimental testing will not be divulged to the clinical team or to the patient.
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic Cases and Inflamed, Non-Septic Comparators:
- •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)
排除标准
- •All Participants:
- •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
研究组 & 干预措施
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial Alpha-defensin assay (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial Neutrophil elastase assay (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial lactate assay (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial C-reactive Protein (CRP) (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial Staphylococcus spp antigen panel (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial Candida spp antigen panel (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial Enterococcus faecalis assay (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial bacterial culture by BacT/Alert (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial Cell count + differential (CBC) (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial Gram Stain (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial Leukocyte Esterase Test Strips (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Serum D-dimer (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Serum Procalcitonin (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Blood Cultures (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: 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)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial Alpha-defensin assay (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial Neutrophil elastase assay (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial lactate assay (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial C-reactive Protein (CRP) (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial Staphylococcus spp antigen panel (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial Candida spp antigen panel (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial Enterococcus faecalis assay (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial bacterial culture by BacT/Alert (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial Cell count + differential (CBC) (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial Gram Stain (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial Leukocyte Esterase Test Strips (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Synovial PCR for Kingella kingae (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Serum Cell count + differential (CBC) (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Serum D-dimer (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Serum Procalcitonin (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Blood Cultures (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: 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)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Synovial PCR for Kingella kingae (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Serum Cell count + differential (CBC) (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Serum erythrocyte sedimentation rate (ESR) (Diagnostic Test)
Inflamed/Infected Joint
Patients undergoing joint aspiration/debridement due to suspicion of septic joint or rheumatologic/inflammatory condition
干预措施: Serum C-reactive Protein (CRP) (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Serum erythrocyte sedimentation rate (ESR) (Diagnostic Test)
Normative Control
Patient undergoing procedure unrelated to infection/inflammation
干预措施: Serum C-reactive Protein (CRP) (Diagnostic Test)
结局指标
主要结局
Sensitivity and specificity of experimental tests
时间窗: 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.
次要结局
未报告次要终点