Alteration of the Immune Response in Bacterial Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ)
研究概览
简要总结
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"
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
cytokin analysis (IL-6, IL-10, IL-17, TNFα, IFNγ)
时间窗: 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
leptin polymorphism analysis
时间窗: 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
adipokin analysis (leptine, adiponectine)
时间窗: 1 month
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
次要结局
未报告次要终点
研究者
Roderick Meckenstock
Principal Investigator
Versailles Hospital