IMMUNOCANDIDA Candida Host Defense Response After Septic Shock in the Critically Ill
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Candidiasis infection occurence
研究概览
简要总结
Septic shock is associated with acquired immunoparalysis which is associated with a high risk of nosocomial acquired infection. Nosocomial candidiasis is associated with a 50% rate of mortality but is difficult to diagnose. The use of colonization indexes and risk factors on the other hand expose to unnecessary use of antifungals. The aim of the present study is to evaluate whether the host response to infection associated with candida biomarkers would help to anticipate the candidiasis onset.
详细描述
Single center prospective observationnal study. Inclusion: all consecutive patients subsequently to a septic shock with no Candida infection.
Measured parameters: host response (HLADR, CD64, inflammatory cytokines consecutive to LPS exposition) and Candida biomarkers (beta D Glucan, Mannan Ag and Ig), demographics, outcome (occurence of Candida nosocomial infection, morbidity and survival)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •Age > = 18 years
- •The patients in toxic shock defined according to the Bone criteria
- •Informed consent of the patient or his reliable person (poursuit consent in this case). Possibility of inclusion according to the emergency procedure with the obligation of research for the consent with the reliable person and with the patient.
- •Obligation of membership or beneficiary to have a national insurance
排除标准
- •Pregnant or breast-feeding women according to the article L1121-5 of the CSP
- •Vulnerable people according to the article L1121-6 of the CSP 9358 _ "
- •Neutropénie 500 / mm3
- •Infection by the HIV, the hepatitis C or B active column
- •Biotherapics (anti-CD20, anti-TNFa, anti-IL-6)
- •Treatments immunosuppresseurs (methotrexate, azathioprine, cyclophosphamide, mycophenolate mofétil, cyclosporine, tacrolimus)
- •Corticosteroid therapy = 1mg / kg of equivalent prednisone for more than a month
- •Toxic shock due to a deep candidiasis in the admission in resuscitation
- •Congenital deficits of Th17 (cutanéo-mucous candidiasis chronicles, syndrome of hyper IgE)
结局指标
主要结局
Candidiasis infection occurence
时间窗: Day 28 survival
Outcome
次要结局
未报告次要终点