Alteration of the Immune Response in Bacterial Infection (ARIIBACT)
The pilot study "ARIIBO" was conducted to analyze changes in immune parameters reported in obese subjects, which had never been the subject of a global study outside of an infectious context, and studied in period septic only sporadically. This study was intended to contribute to a better understanding of the probably adverse impact of obesity on the immune response to bacterial infections, and to describe a specific immunological profile of an infectious excess risk in obese subjects.
In terms of infection, obesity is a risk factor due to "mechanical" and pharmacodynamic variations, but also to the immune system. One of the best studied immunological parameters in obese patients, leptin resistance, is associated with a decrease in innate and adaptive immunity through a modification of the lymphocyte and cytokine profile.
It is important to compare the data collected in obese patients infected (first study called "ARIIBO"), with those of non-obese subjects presenting the same type of infection, which will be included in the study "ARIIBACT"
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
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Le Chesnay、法国
- CH Versailles
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age between 18 and 80 years
- BMI 18 to 25
- presence of a bacterial infection
- pneumopathy (documented or probable)
- acute pyelonephritis / prostatitis
- skin and soft tissue infection (erysipelas, fasciitis, excluding pressure ulcers)
- cholecystitis / cholangitis,
- surgical site infection
- signed informed consent
Exclusion Criteria:
- patients with documented viral, parasitic or mycotic infections
- patients with bacterial infection> 4 weeks (eg endocarditis, osteoarticular infections)
- patients followed in intensive unit care
- patients with progressive cancerous pathology or malignant hemopathy diagnosed in the previous five years
- patients with systemic diseases (connective tissue diseases, vasculitis)
- known immunodepression syndrome (CVID, HIV ...)
- immunosuppressive therapy in progress until less than one month before inclusion (corticosteroids, DMARDs, biotherapies, hydroxychloroquine)
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Interventional arm
blood sample before, during and after treatment for infection
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blood sample before, during and after infection treatment
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ)
大体时间：1 month
|
Description of an immunological profile of inflammation using current inflammatory cytokines during sepsis in non-obese subjects in comparison with this same profile in obese subjects
|
1 month
|
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adipokin analysis (leptine, adiponectine)
大体时间：1 month
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Description of the kinetics of 2 cytokines more speficically involved in obesity (leptine, adipokinine) during sepsis in non-obese subjects in comparison with this same profile in obese subjects
|
1 month
|
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leptin polymorphism analysis
大体时间：1 month
|
Description of the genetic polymorphism of leptine and leptine receptor in non-obese subjects in comparison with this same profile in obese subjects
|
1 month
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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