Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus (FLUVALENTINE)
2017年12月4日 更新者：Central Hospital, Nancy, France
Secondary bacterial influenza pneumonia caused by Panton-Valentine Leukocidin Positive Staphylococcus aureus is a rare complication but with poor prognosis. This pathology seems to affect young patients (20-40 years) without any medical history. Since the influenza pandemic of 2009, this complication is more and more mentioned, sought and diagnosed. However, the literature is poor, consisting of case reports, experimental studies on murine models, and low-power studies.
The main objective is to evaluate the mortality in intensive care units of patients post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive Staphylococcus aureus
研究概览
地位
未知
研究类型
观察性的
注册 (预期的)
35
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
-
-
-
Nancy、法国、54000
- 招聘中
- Baux
-
接触：
- Elisabeth Baux, MD
- 电话号码：+33 03 83 15 28 65
- 邮箱：e.baux@chru-nancy.fr
-
-
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
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients hospitalized in intensive care units for the management of influenza pneumonia infected with Panton-Valentine Leukocidin Positive Staphylococcus aureus over a retrospective period from 2009 to winter 2016-2017.
描述
Inclusion Criteria:
- Patient treated for post-influenza bacterial pneumonia due to a Panton-Valentine Leukocidin positive Staphylococcus aureus in intensive care unit
Exclusion Criteria:
- Minor patient
- Patient under protective measurement
- Absence of bacteriological and / or virological documentation
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
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 |
|---|---|---|
|
Number of dead patients
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
All cause of mortality
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Demographic data relating to age
大体时间：Baseline
|
age
|
Baseline
|
|
Demographic data relating to sex
大体时间：Baseline
|
sex
|
Baseline
|
|
Respiratory failure
大体时间：Baseline
|
PaO2/iFO2 value
|
Baseline
|
|
Demographic data relating to immunosuppression
大体时间：Baseline
|
Amount of polynuclear neutrophils (G/L)
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
大体时间：Baseline
|
hospitalization
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
大体时间：Baseline
|
dialysis
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
大体时间：Baseline
|
surgery
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
大体时间：Baseline
|
presence of percutaneous or long-term catheter
|
Baseline
|
|
Clinical data relating to pre-admission antibiotics
大体时间：Baseline
|
type of antibiotic prescribed
|
Baseline
|
|
Clinical data in the initial phase relating to SAPS 2 score
大体时间：Baseline
|
Simplified acute Physiology score (SAPS2) score between 0 and 163 and a predicted mortality between 0% and 100%
|
Baseline
|
|
Clinical data in the initial phase relating to SOFA admission
大体时间：Baseline
|
Sequential Organ Failure Assessment (SOFA)
|
Baseline
|
|
Clinical data in the initial phase relating to neutropenia
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
neutropenia
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to neutropenia
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
thrombocytopenia
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to metabolic acidosis
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
metabolic acidosis
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to oxygen dependence
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
oxygen dependence
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to hyperthermia
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
hyperthermia
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to chills
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
chills
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to headhache
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
headache
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to productive cough
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
productive cough
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to dyspnoea
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
dyspnoea
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to acute respiratory failure
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
acute respiratory failure
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to hemoptysis
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
hemoptysis
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to uni - or multi - lobar infiltration on chest X - ray or CT scan
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
uni - or multi - lobar infiltration on chest X - ray or CT scan
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to pleural effusion
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
pleural effusion
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
necrotizing pneumonitis
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to renal failure
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
renal failure according to KDIGO classification
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Prognostic factors for this pathology
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Time to diagnosis of influenza infection and Panton-Valentine Leukocidin Positive Staphylococcus aureus Haemoptysis, leukopenia, thrombocytopenia, acute respiratory distress syndrome (ARDS), PaO2 / Fi02, inotropic support
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Complications
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Complications related to Septic shock ARDS: according to Berlin 2009 classification Extra corporeal vein-venous or veino-arterial oxygenation membrane (ECMO VV or ECMO VA) Ischemic limb Pneumothorax Acute renal failure according to Kdigo classification Disseminated intravascular coagulation (DIC) (2) Cardiogenic shock / cardiogenic pulmonary acute edema Multi visceral failure syndrome (3) Use of surgery: abscess drainage, lobectomy, amputation, laparotomy and colonic resection ...
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Collection of infectious samples
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Bacteriological, Parasitological, Virological
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Probabilistic antibiotherapy
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Collection of probabilistic antibiotherapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Probabilistic antibiotherapy
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Duration of probabilistic antibiotherapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Prescribed antibiotic therapy
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Collection of Prescribed antibiotic therapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Prescribed antibiotic therapy
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Duration for the appropriate anti-toxin treatment
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Collection of the date of introduction of adapted antibiotic therapy
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Collection of the date of introduction of adapted antibiotic therapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Number of patients with Influenza type A
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Number of patients with Influenza type A
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Number of patients with Influenza type B
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Number of patients with Influenza type B
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Date of initiation of anti-viral treatment in relation to the onset of symptoms and duration of anti-viral treatment
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Date of initiation of anti-viral treatment in relation to the onset of symptoms and duration of anti-viral treatment
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Dosage of antiviral treatment
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Dosage of antiviral treatment
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Number of serious influenza infections per year and per center with early and late deaths
大体时间：During Length of stay in intensive care unit (an average of 2 weeks)
|
Mortality caused by serious inflenza infections
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
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。
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)
2017年10月1日
初级完成 (实际的)
2017年10月20日
研究完成 (预期的)
2018年3月1日
研究注册日期
首次提交
2017年11月18日
首先提交符合 QC 标准的
2017年12月4日
首次发布 (实际的)
2017年12月11日
研究记录更新
最后更新发布 (实际的)
2017年12月11日
上次提交的符合 QC 标准的更新
2017年12月4日
最后验证
2017年11月1日
更多信息
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.