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Lung Microbiota and VAP Development (PULMIVAP) (PULMIVAP)

"Pulmonary Microbiota and Related Immunity Role in Predicting Ventilator Associated- Pneumonia (VAP) Development in Mechanical Ventilated Patients"

Ventilator-associated pneumonia (VAP) refers to a lower respiratory tract nosocomial infection acquired >48h after being intubated in Intensive Care Units. Pathogenesis of VAP is mechanical and associated with microaspiration and leakage of oropharyngeal secretions around the endotracheal tube. A novel approach to VAP will attempt to explore how the abrupt ecological order of acute infection (high bacterial biomass, low community diversity) emerges from the dynamic homeostasis of a pre-existing ecosystem in which lung microbiota and local immunity interaction play their essential role.

Therefore, the investigators aim to explore if oral and lung microbiota modifications with local immunity changes, contribute in the pathogenesis of VAP in patients intubated for non-pulmonary reasons. Early changes in the host microbiota with the innate immunity system impairs tissue homeostasis and may represent a new distinct condition and a potential tool for early diagnosis and prevention of VAP.

研究概览

地位

招聘中

条件

详细说明

Several factors are involved in the pathogenesis of VAP: the presence of endotracheal tube, the creation of bacterial biofilms around the device, host characteristics (comorbidities, surgery, antibiotic exposure) and, finally, immunological factors (including modulation of cytokine expression). In this study, patients mechanically ventilated for non-pulmonary reasons, will be followed up to 15 days of ventilation, estubation or death (whichever comes first). For microbiota analysis, all patients who develop VAP in the first 15 days of MV will be selected and matched (1:1; by center, gender, age (+/- 10 years), reason for intubation, duration of intubation), with a patient who do not developed VAP during MV. The optimal matching algorithm will be used to identify the control group that minimizes the total intra-pair dissimilarity.

The investigators plan to enroll about 700 MV patients for non-pulmonary conditions in order to describe VAP and non-VAP patients' characteristics identify. The investigators estimate that at least 70 patients will develop VAP in the first 15 days of MV. Microbiota and immunological analysis will be longitudinally performed on tracheal aspirate samples and oro-pharyngeal swab. The investigators will performe microbiota analyses on tracheal aspirate and oropharyngeal swab according to the following time schedule:

  • VAP patient, 3 times: intubation (T0), the 24h before VAP development (T pre-VAP) and at VAP development (T-VAP).
  • non-VAP patient, 2 times: intubation (T0) and a second sample, selected at the time point (day), corresponding to T-VAP of his/her matched VAP-patient (T no-VAP).

The investigators will perform immunological analysis on tracheal aspirate for all patients at intubation and at T-VAP or T no-VAP time.

研究类型

观察性的

注册 (预期的)

700

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • MI
      • Milan、MI、意大利、20112
        • 招聘中
        • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

All adult patients mechanicaly ventilated for non pulmonary conditions

描述

Inclusion Criteria:

  • Older than 18 years
  • Patients ventilated for reasons other than pulmonary failure with an expected need for MV longer than 48 hours

Exclusion Criteria:

  • Admission in ICU with a pneumonia
  • Clinical Pulmonary Infectious Score (CPIS) > 6
  • Antibiotic therapy > 3 days prior to the start of MV

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
Mechanicaly ventilated adult patients for non-pulmonary conditions

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Lung/oral microbiota and VAP development
大体时间:(Time frame for VAP patients: intubation (T0), 24h before VAP development (T pre- VAP) and at VAP development (T-VAP). Time frame for non-VAP patients: intubation (T0), samples corresponding to T-VAP of matched VAP patients (T no VAP))

Alfa and beta diversity variation based on 16S-rRNA sequencing in tracheal aspirates and oral samples.

To explore the association between the composition and related changes over time of the lung/oral microbiota and VAP development has been used the measure of the alfa-diversity (number of different OTUs in each sample) and beta-diversity (similarity between samples in terms of OTUS composition).

(Time frame for VAP patients: intubation (T0), 24h before VAP development (T pre- VAP) and at VAP development (T-VAP). Time frame for non-VAP patients: intubation (T0), samples corresponding to T-VAP of matched VAP patients (T no VAP))

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年9月10日

初级完成 (预期的)

2022年11月1日

研究完成 (预期的)

2023年1月1日

研究注册日期

首次提交

2021年2月24日

首先提交符合 QC 标准的

2021年4月13日

首次发布 (实际的)

2021年4月19日

研究记录更新

最后更新发布 (实际的)

2021年4月19日

上次提交的符合 QC 标准的更新

2021年4月13日

最后验证

2021年2月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

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研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

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