Multicenter, Diagnostic and Prospective Study to Differentiate Child Septic and Inflammatory Arthritis by Comparative Analysis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Qualitative analysis of new cellular markers that discriminate inflammatory and infectious arthritis
研究概览
简要总结
The purpose is to found new biomarker that differentiate septic arthritis and Juvenile Idiopathic Arthritis in children. Synovial liquid and blood samples with proteomic, MiRNA searching, multiplex cytokine analysis and cellular phenotyping, will be analysed. The results for each data will be compared in function of the disease to search discriminant markers. On behalf with this result specific pathways could be identified .
详细描述
This a multicentric prospective study that compares biological fluids as synovial liquid and blood samples to find biomarkers that could distinguish septic arthritis and juvenile idiopathic arthritis. Prospectively, patients will be recruited under the age of 15 who are in care for septic or inflammatory arthritis at the University Hospitals of Montpellier, Lyon, Nimes and Toulouse. Patients should have an indication of blood and synovial as part of their management :
Group A: acute juvenile arthritis with suspicion of bacterial infection, , confirmed on a bacteriological plan, either by culture of the articular liquid or by blood culture, or by molecular biology in the articular liquid.
Group B: Idiopathic juvenile arthritis and control topics (Group C). In this project, the aim is to analyze all in all 50 articular liquids and serum of inflammatory arthritises (Group B), and 30 articular liquids and serum of infectious confirmed arthritises (Group A) which will require the inclusion about 50 possibly septic arthritis. The diagnosis of infectious arthritis is not immediate, he(it) is confirmed at the latest three weeks after the draining. So a group of control will be constituted.
Group C: the blood of 20 healthy children matched by the age and at the sex in the groups A and B will be collected to analyze elements studied in the blood.
- Inclusion criteria :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group A and group B:
- •Subject of more than 6 months and under age 15 years,
- •Presenting acute arthritis taken care in the University Hospitals of Montpellier, Nimes, Toulouse or Lyon, and requiring an articular puncture,
- •Child benefiting from a social security system,
- •Collection of the consent of the legal parents/representatives,
- •Subject of more than 6 months and under age 15 include,
- •Taken care in the University Hospital of Montpellier, and requiring a venous draining,
- •Child benefiting from a social security system,
- •Collection of the consent of the legal parents/representatives
排除标准
- •Group A and group B:
- •Contraindication in an articular draining: platelet 50 000/mm3, pathologic hemostasis
- •Treatment by biological therapy, corticoids or other immunosuppressant treatment in the month preceding the articular draining,
- •antibiotic begun more than 24 hours before the inclusion.
- •Patient achieves of an inflammatory chronic pathology
- •Patient having presented an infectious episode in the previous 8 days
- •Patients under immunosuppressor or anti-infective
研究组 & 干预措施
inflammatory arthritis (group B)
Patients with idiopathic juvenile arthritis
septic arthritis (group A)
Patients with acute juvenile arthritis with suspicion of bacterial infection,confirmed on a bacteriological plan, either by culture of the articular liquid or by blood culture, or by molecular biology in the articular liquid;
control (group C)
Healthy children who are matched by the age and at the sex in the groups A and B, to analyze elements studied in the blood.
结局指标
主要结局
Qualitative analysis of new cellular markers that discriminate inflammatory and infectious arthritis
时间窗: 1 day
Identify blood sampling cellular markers (lymphocytes and monocytes) of Arthritis childhood
Qualitative analysis of new biological markers (proteic) that discriminate inflammatory and infectious arthritis
时间窗: 1 day
Identify blood sampling proteic markers of Arthritis childhood
Qualitative analysis of new biological markers (cytokine) that discriminate inflammatory and infectious arthritis
时间窗: 1 day
Identify blood sampling markers (cytokine : interleukin 2, interleukin 4, interleukin 6, interleukin 7, tumor necrosis factor alpha (TNF)) of Arthritis childhood
次要结局
- Qualitative analysis of inflammatory process markers(1 day)