跳至主要内容
临床试验/NCT04271345
NCT04271345Unknown不适用

Analysis of the Pulmonary Microbiota in a Cohort of Critically Ill Patients Admitted to the Intensive Care Unit. Prospective, Observational Trial.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年11月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients

研究概览

简要总结

Our study aims to evaluate the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables among critically ill patients admitted to the intensive care unit (ICU). In patients undergoing invasive mechanical ventilation, an aliquot of bronchoalveolar lavage (BAL) fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques.

详细描述

Traditionally, microbiological investigations and clinical trials have contributed to the definition of lower airways as a physiologically sterile district, whose microbiological balance is altered when a respiratory infectious process occur. Actually, the introduction of molecular study methods aiming at the identification of pathogens through genomic sequencing questioned the pardigm of "one bug-one disease", according to which we usually tend to consider a bronchial or pulmonary infectious event as due to the pathogenic role of a single exogenous microorganism. In such a contest, there are truly few data dealing with the characterization of respiratory microbiota in human BAL as well as with the major determinants of this phenomenon and the possible impact on clinical and microbiological outcomes. Our study, although it's a pilot one, aims to evaluate these aspects in a larger cohort of critically ill patients, observing the relationship between the heterogeneity of pulmonary microbiota and clinical and outcome variables. In patients undergoing invasive mechanical ventilation, an aliquot of BAL fluid will be used in the microbiology laboratory for the analysis of respiratory microbiota through next-generation sequencing technologies and validate computational techniques. For each enrolled patient, we will register demographic, clinical and laboratory variables. The benefits deriving from this study lay in the possibility of improving the understanding of characteristics of critical patient's pulmonary microbioma and its clinical impact. Such an information meets the increasingly topical need to customize medical interventions, especially in the context of critically ill patients.

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

入选标准

  • execution of bronchoalveolar lavage sampling, either for clinical indications or in the context of surveillance programs
  • acquisition of an informed consent

排除标准

  • presence of significant coagulation abnormalities and/or severe respiratory failure
  • clearly bloody BAL sample
  • small quantity of BAL sample (<5 ml)

结局指标

主要结局

Description of the biodiversity of pulmonary microbioma in a cohort of critically ill ICU patients

时间窗: 36 months

This aim will be achieved through the use of next-generation sequencing technologies and validate computational techniques, allowing us to taxonomically classify as well as to compare the germs present in BAL samples of ICU patients

次要结局

  • Mortality at 28 and 90 days(36 months)
  • Clinical cure, defined by the discontinuation (> 72 hours) from mechanical ventilation(36 months)
  • Microbiological eradication, defined by a sterile BAL(36 months)
  • Duration of mechanical ventilation, in days(36 months)
  • Duration of cathecolamins administration, in days(36 months)
  • Hospital and ICU lenght of stay, in days(36 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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