Analysis of TLRs and Lectin Gene Polymorphisms. Impact on Yeast Colonization in Hospitalized Patients and on Adaptive Response Against Yeast Glycans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,200
- 试验地点
- 6
- 主要终点
- Frequency of polymorphisms
研究概览
简要总结
It is proposed to carry out the study in three medical or surgical intensive care units (ICU) in the CHRU, Lille, and the CHU, Besançon. In all patients admitted to these ICU (see Figure 2), a corrected index of colonisation (CIC) will be determined and blood samples will be taken for genotyping of the lectins MBL, Dectin-1 and Galectin-3 and for serology. Over the duration of hospitalisation (on average 28 days) and weekly, fungal colonisation will be assessed in all patients (according to the CIC), and antibodies to yeast glycans will be determined by a simultaneous multiparametric analysis involving several families of natural or synthetic antigens, and the detection of circulating antigens (mannan and β-1,3 glucan).
详细描述
Determination of the CIC:
The CIC will be determined on admission and then once a week during hospitalisation. This will be carried out on a fixed day for all patients; we will avoid determining the CIC any closer than 2 days apart. It is not planned in this study to modify the therapeutic strategy of the ICU services. The strains isolated will be stored in glycerol solution at -80°C. The specimens for genetic and serological analysis will be stored centrally in a local mycology laboratory.
Genotyping of lectin genes and TLRs:
Two tubes containing 6 ml of blood in EDTA will be taken from each patient for extraction of DNA
Serological study, detection of antibodies to yeast glycans:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, ≥18 years of age, admitted to medical or surgical ICU for a duration of >48 h, irrespective of their colonisation status.
排除标准
- •-Patient (or their representative) who refuses to participate in the study or to undergo the procedures required for the investigations (mycological sampling in order to determine the CIC, blood sampling for genotyping of DNA and for serology)
- •Previous antifungal treatment (in the 15 days preceding admission to the ICU).
- •A CIC value based on an insufficient number of sampled sites (<6).
- •Neutropenic patients
- •Patients who are receiving immunosuppressants (transplanted, grafted...)
- •Patients who do not have universal cover or Social Security cover
结局指标
主要结局
Frequency of polymorphisms
时间窗: From date of inclusion until the last day hospital stay (at once a week)
the frequency is measured for the association between the presence of a polymorphism and colonization by Candida sp. frequency of polymorphisms at least one lectin gene or TLRs between some colonized patients (G5) and the non-colonized patients (G2).
次要结局
- Genotyping of lectin genes and toll-like-receptors (TLRs)(From date of inclusion until the last day hospital stay (at once a week))
- Colonization index(at admission and weekly for at least two weeks after.)
- Functional tests on peripheral blood mononuclear cells (PBMC)(at admission and weekly for at least two weeks after.)