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Severe Legionellosis Cases Admitted to Grenoble University Hospital, 2006-2011. (LEGIOGRE)

2016年8月30日 更新者:AdministrateurDRC、University Hospital, Grenoble

Molecular Epidemiology of Legionellosis in Grenoble Region

The study aimed at further describing the epidemiological, clinical, diagnostic and prognostic features in legionellosis cases admitted to Grenoble University Hospital during the 2006-2011period. The investigators also tested lower respiratory samples collected from these patients during their routine medical care, using a number of molecular tools allowing determination of the involved Legionella species, the bacterial load, and the presence of antibiotic resistant mutants. Our primary goal was to define biological markers that could predict severity and outcome of infection in legionellosis cases requiring hospitalization.

研究概览

详细说明

Patients admitted to Grenoble University Hospital between 2006 and 2011 for severe legionellosis were retrospectively included in the study.

Clinical, epidemiological, diagnostic and prognostic data of these patients were recorded retrospectively.

Lower respiratory samples collected from these patients on a routine basis for microbiological analysis, especially Legionella culture, were tested using traditional microbiological methods. The remaining part of these samples was stored at -80°C fur further molecular analyses.

The molecular tools developed by our bacteriology laboratory included the following: a real-time polymerase chain reaction (qPCR) test allowing detection and differentiation of L. pneumophila and other Legionella species; a qPCR test allowing determination of the Legionella DNA load in lower respiratory samples; a qPCR allowing detection of gyrA (the gene encoding subunit A of DNA gyrase) mutations that the investigators previously determined to be correlated with fluoroquinolones resistance in L. pneumophila; a high-throughput sequencing approach allowing confirmation of gyrA mutations and determination of the percentage of mutated alleles.

The microbiological data, especially those obtained with the developped molecular tools, were tentatively correlated with the severity and outcome of infection in our patients' cohort.

研究类型

观察性的

注册 (实际的)

82

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 至 99年 (成人、年长者)

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

82 unrelated legionellosis cases 64 males, 18 females mean age: 55 years, range: 27-97 years severe legionellosis requiring hospitalization

描述

Inclusion Criteria:

  • age higher than 18 years
  • proven legionellosis case (positive culture and/or PCR and/or urinary antigen test)
  • severe case requiring hospitalization

Exclusion Criteria:

  • age under 18 years
  • pregnant women

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
干预/治疗
Severe legionellosis cases
Patients admitted to Grenoble University Hospital for severe legionellosis between 2006 and 2011.
qPCR and high-throughput DNA sequencing testing of lower respiratory tract samples collected routinely in patients with severe legionellosis

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
Legionella DNA load in lower respiratory tract samples
大体时间:through study completion, an average of 1 year
Real-time polymerase chain reaction (qPCR) dosages in lower respiratory tract samples collected on a routine basis all over the hospitalization duration
through study completion, an average of 1 year

次要结果测量

结果测量
措施说明
大体时间
Fluoroquinolones resistant gyrA mutants in lower respiratory tract samples
大体时间:through study completion, an average of 1 year
Real-time polymerase chain reaction (qPCR) and high-throughput DNA sequencing testing of lower respiratory tract samples collected on a routine basis all over the hospitalization duration
through study completion, an average of 1 year

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

  • 研究主任:Hélène Sabbah-Guillaume, Director、Direction of Research and Medical Innovation (DRCI)

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

2009年9月1日

初级完成 (实际的)

2011年12月1日

研究完成 (实际的)

2014年12月1日

研究注册日期

首次提交

2016年8月22日

首先提交符合 QC 标准的

2016年8月30日

首次发布 (估计)

2016年8月31日

研究记录更新

最后更新发布 (估计)

2016年8月31日

上次提交的符合 QC 标准的更新

2016年8月30日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • Grenobole University Hospital

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Biological data are available at the bacteriology laboratory. Clinical data are available at the participating medical wards.

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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