Identification of Gut Microbiome Biomarkers Associated to Acquisition of Enterobacteriae Highly Resistant to Third Generation Cephalosporines Following Ceftriaxone Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 143
- 试验地点
- 2
- 主要终点
- Identification of gut microbiome biomarkers
研究概览
简要总结
Patients receiving Ceftriaxone 1 gram or 2 grams per day during their presence in emergency unit of hospital whatever their medical condition, will be included.
Rectal swabs will be collected at inclusion and at days 5 and 30 to perform analysis.
Analysis will be performed to characterize gut microbiome in order to detect intestinal microbiome profiles significantly associated with protection against colonization by third generation cephalosporin resistant Enterobacteriae.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years
- •Able to comply with study requirement and to provide informed consent
- •Outside the context of tutorship and / or guardianship, affiliated to the Social Security Regime and having consented to participate in the ARCMI study.
- •Patient receiving ceftriaxone (1 gram or 2 grams per day) in the emergency department
排除标准
- •Patients with acute anorectal pathology incompatible with the swabbing strategy or digital rectal examination.
- •Prescription of another dosage of ceftriaxone (more than 2 grams per day)
- •Patient with inflammatory bowel disease
- •Allergy or contraindication to betalactamines and cephalosporins
结局指标
主要结局
Identification of gut microbiome biomarkers
时间窗: 30 days
The use of culture-independent techniques, metagenomics and metabolomics, will allow an exhaustive analysis of the intestinal microbiome in order to detect intestinal microbiome profiles (including species, modules, metabolites) significantly associated with protection against colonization by Enterobacteriae resistant to Cephalosporine. Acquisition of a risk index to Enterobacteriae resistance to third generation cephalosporin will be measured by the method developed by Montassier et al, 2016, Genome medicine.
次要结局
- Identification of gut microbiome biomarkers(5 days)