NCT01551667已完成不适用
Observational and Comparative Study on the Immune Response of Patients With Chronic, Staphylococcus Aureus-infected Wounds (Localized Infections Versus Bacteremia)
Centre Hospitalier Universitaire de Nīmes6 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2012年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 6
- 主要终点
- Humoral immune response
研究概览
简要总结
The primary objective of this study is to detect differences in anti-S. aureus antibody assays (IgM, IgA, IgG and its subclasses) between (1) a group of patients with bacteremia due to a chronic wound (cases) and (2) a group of patients with localized chronic wound infections (control).
详细描述
Secondary objectives include:
- To propose a diagnostic marker of bacteraemia based on the detection of anti-S. aureus by xMAP technology
- To evaluate the kinetics of the humoral immune response to S. aureus in patients with bacteraemia
- To evaluate the virulence of S. aureus isolated from chronic, infected wounds
- To enrich the Nîmes University Hospital biobank
- To evaluate the prevalence of different antibodies within each group
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 6 months of follow up
- •Patients consulting at the departments of Diabetology, Dermatology or Infectious Diseases of the participating hospitals
- •inaugural or recurrent diabetic foot/ankle ulcers of Grade 2-4, or (2) who have an infected leg ulcer (arterial, venous, or mixed.
- •Absence of bacteriemia
- •Presence of bacteriemia
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient does not have a chronic wound
- •Patient with grand 1 ulcer
- •Patient's wound/ulcer is not infected
- •Patient's would/ulcer is infected, but not involving S. aureus
结局指标
主要结局
Humoral immune response
时间窗: 6 months
Humoral immune response via production of anti-staphylococci antibodies in patients with bacteraemia versus those with localized wound infections. 22 antibodies will be tested(quantitative determination by xMAP technology).
次要结局
- Antibody production kinetics(6 months)
- Presence / absence of clonal complexes of the S. aureus strains(6 months)
研究者
研究点 (6)
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