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Understanding Childhood Infection, Inflammation and Allergy

2022年4月8日 更新者:Imperial College London

A Comprehensive, Long-term Integrated Programme to Study the Aetiology and Immunopathology of Childhood Infectious, Inflammatory and Allergic Disease, Using the Large Patient Base of Children Attending St Mary's Hospital, London

This proposal represents a unified programme supported by both clinical and academic staff in the Departments of Paediatrics at Imperial College and St Mary's Hospital, Southampton Hospital and John Radcliffe Hospital (Oxford). St Mary's Hospital is the hub of a paediatric network for West London, and forms part of the Paediatric Intensive Care Network for the London region, with potential access to a population of 3 million children.

We aim to improve diagnosis and understanding of children with infectious, inflammatory and allergic conditions. Our study will establish well-characterised cohorts of patients with defined conditions, in whom microbiological and patient samples will be used to understand the contribution of genetic background, differential gene expression, proteomics and the pathogen type to the disease process.

Unwell children coming to hospital through any route will be invited to join the study. Entering the study will entail the child having blood taken for research purposes in addition to the clinically indicated tests. We will also recruit well (control) children who are having blood tests performed for elective purposes, such as surgery.

In addition, children presenting with an illness that is likely to have an infectious aetiology will also have samples collected for microbiological diagnosis. Those samples taken for ordinary diagnostic purposes (such as blood, urine, cerebrospinal fluid (CSF), bronchoalveolar lavage (BAL) fluid or nasal brushings for epithelial cell cultures) would also be used for state-of-the-art diagnostic techniques, in order to maximise the likelihood of confirming a microbiological diagnosis. Where healthy, uninfected children are having invasive procedures, such as lumbar punctures, we would aim to recruit these children as controls and collect biological samples such as CSF samples.

This bid addresses the need for translational research in paediatrics, by building on the world-class basic science and clinical paediatric base at Imperial College and St Mary's Hospital.

研究概览

地位

完全的

详细说明

There is currently little understanding of the mechanisms by which respiratory infections can cause severe illness and death. The emergence of Influenza A subtype (H1N1) as a major cause of childhood severe illness in 2009 permitted further study of how this virus triggers severe disease, and how the inflammatory response to H1N1 differs from other infections. It is likely that host-mediated inflammatory processes triggered by the infecting agent contributes to severe illness. In addition, viral infection induces profound changes in the innate immune response to common bacterial pathogens, with increased bacterial colonisation of normally sterile lower airway. Thus both host and bacterial factors may contribute to lung damage in severe respiratory infection.

This study was initiated to identify the aetiology and immunopathologic mechanisms of childhood respiratory infection (Immunopathology of Respiratory Infection Study - IRIS), recruiting children with suspected respiratory infection or respiratory failure (and controls). This dataset will provide a unique resource for further study of disease mechanisms in children with a range of infections including H1N1/09 infection, Respiratory Syncytial Virus (RSV), Rhinovirus, other common respiratory viruses and severe bacterial infections.

研究类型

观察性的

注册 (实际的)

902

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。

学习地点

      • London、英国、W2 1NY
        • St Mary's Hospital, Paddington

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

不超过 16年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Unwell children coming to St Mary's Hospital, Southampton Hospital or John Radcliffe Hospital (Oxford) through any route (Emergency Department, wards, intensive care)

描述

Inclusion Criteria:

  • children presenting via any means to Hospital
  • children needing blood tests for any clinical reason
  • children who have presented because of a condition consistent with an infectious, inflammatory or allergic process

Exclusion Criteria:

  • aged 17 or older
  • children re-presenting with the same condition
  • concern that the study is not fully understood by the parent or guardian

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

队列和干预

团体/队列
Infection, inflammation or allergy

Children presenting via any means to St Mary's Hospital; this would include the A&E department, the general and infectious disease wards and the paediatric intensive care unit.

Children needing blood tests for any clinical reason Children who, in the clinical judgement of the doctor assessing them, have presented because of a condition consistent with an infectious, inflammatory or allergic process

controls
children who do not have an infectious, inflammatory or allergic condition, who anyway require blood tests for clinical reasons

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
What Are the Bacterial and Viral Causes of Acute Illness in Children Presenting to a UK General Hospital, Tertiary Paediatric Infectious Disease Unit and Paediatric Intensive Care Unit?
大体时间:Participants were monitored for outcome throughout their stay in hospital, and received follow-up review at 10 days
number of participants with phenotype of definite bacterial or definite viral disease, based on culture or molecular investigations of samples from a sterile site
Participants were monitored for outcome throughout their stay in hospital, and received follow-up review at 10 days

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。

调查人员

  • 首席研究员:Michael Levin、Imperial College London

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)

2009年7月20日

初级完成 (实际的)

2018年8月30日

研究完成 (实际的)

2019年6月11日

研究注册日期

首次提交

2009年11月30日

首先提交符合 QC 标准的

2009年11月30日

首次发布 (估计)

2009年12月1日

研究记录更新

最后更新发布 (实际的)

2022年11月21日

上次提交的符合 QC 标准的更新

2022年4月8日

最后验证

2022年4月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CRO1330

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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