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临床试验/NCT02928367
NCT02928367Unknown不适用

The Effect of Leukocyte Dna mEthylation and micRoBIOME Diversity on Host Defense Mechanisms During Community-acquired Pneumonia

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2016年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
231
试验地点
1
主要终点
Alterations in leukocyte DNA methylation

研究概览

简要总结

Community-acquired pneumonia (CAP) represents a major health care problem and mortality and morbidity associated with severe pneumonia remain considerable, despite state of the art care.

While the role of altered DNA methylation in cancer has been widely studied, knowledge of its impact on antibacterial defense is highly limited. In addition, recent preclinical studies showed that the gut and respiratory microbiota contributes to host defense against bacterial pneumonia.

This study aims to explore a completely novel research area linking the extent of DNA methylation in blood leukocyte (monocytes and neutrophils) and function of gut and respiratory microbiota on the influence of innate immune responses to and host defense against CAP

详细描述

Rationale:

Community-acquired pneumonia (CAP) represents a major health care problem and mortality and morbidity associated with severe pneumonia remain considerable, despite state of the art care.

While the role of altered DNA methylation in cancer has been widely studied, knowledge of its impact on antibacterial defense is highly limited. In addition, recent preclinical studies showed that the gut and respiratory microbiota contributes to host defense against bacterial pneumonia.

This study aims to explore a completely novel research area linking the extent of DNA methylation in blood leukocyte (monocytes and neutrophils) and function of gut and respiratory microbiota on the influence of innate immune responses to and host defense against CAP.

Primary Objectives:

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Clinical suspicion of a new episode of acute respiratory tract infection
  • Primary reason for presentation is clinical suspicion of a new episode of acute respiratory infection; admission to the hospital is NOT a requirement
  • Evident new or progressive infiltrate, consolidation, cavitation, or pleural effusion on the chest X ray or CT scan made for diagnostic (non-research) purposes
  • Onset of the following symptoms within the last 7 days:
  • At least one respiratory symptom (cough, sore throat, runny or congested nose, dyspnea)
  • At least one systemic symptom (fever, headache, muscle ache, sweats or chills or tiredness).

排除标准

  • Patient lacks capacity to provide informed consent
  • No informed consent is provided by patient
  • Patient has been transferred from another hospital
  • Patient is enrolled in an interventional clinical study of an anti-infective or immunomodulatory therapy
  • Patient has received any type of oral or systemic antibiotics for more than 48 hours prior to hospital presentation.

结局指标

主要结局

Alterations in leukocyte DNA methylation

时间窗: day 0

次要结局

  • Composition and function of the gut and nasopharyngeal microbiota(day 28)
  • Alterations in leukocyte DNA methylation(day 28)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

T. van der Poll

prof. dr.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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