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
調査の概要
状態
わからない
研究の種類
観察的
入学 (予想される)
35
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Nancy、フランス、54000
- 募集
- Baux
-
コンタクト：
- Elisabeth Baux, MD
- 電話番号：+33 03 83 15 28 65
- メール：e.baux@chru-nancy.fr
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of dead patients
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Demographic data relating to age
時間枠：Baseline
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age
|
Baseline
|
|
Demographic data relating to sex
時間枠：Baseline
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sex
|
Baseline
|
|
Respiratory failure
時間枠：Baseline
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PaO2/iFO2 value
|
Baseline
|
|
Demographic data relating to immunosuppression
時間枠：Baseline
|
Amount of polynuclear neutrophils (G/L)
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
時間枠：Baseline
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hospitalization
|
Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
時間枠：Baseline
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dialysis
|
Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
時間枠：Baseline
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surgery
|
Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
時間枠：Baseline
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presence of percutaneous or long-term catheter
|
Baseline
|
|
Clinical data relating to pre-admission antibiotics
時間枠：Baseline
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type of antibiotic prescribed
|
Baseline
|
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Clinical data in the initial phase relating to SAPS 2 score
時間枠：Baseline
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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
時間枠：Baseline
|
Sequential Organ Failure Assessment (SOFA)
|
Baseline
|
|
Clinical data in the initial phase relating to neutropenia
時間枠：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
時間枠：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)
|
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Clinical data in the initial phase relating to metabolic acidosis
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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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
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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oxygen dependence
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to hyperthermia
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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hyperthermia
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to chills
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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chills
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to headhache
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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headache
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to productive cough
時間枠：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
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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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
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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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
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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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
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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uni - or multi - lobar infiltration on chest X - ray or CT scan
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During Length of stay in intensive care unit (an average of 2 weeks)
|
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Clinical data in the initial phase relating to pleural effusion
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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pleural effusion
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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necrotizing pneumonitis
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During Length of stay in intensive care unit (an average of 2 weeks)
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Clinical data in the initial phase relating to renal failure
時間枠：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
時間枠：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
時間枠：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 ...
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During Length of stay in intensive care unit (an average of 2 weeks)
|
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Collection of infectious samples
時間枠：During Length of stay in intensive care unit (an average of 2 weeks)
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Bacteriological, Parasitological, Virological
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
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Probabilistic antibiotherapy
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2017年10月1日
一次修了 (実際)
2017年10月20日
研究の完了 (予想される)
2018年3月1日
試験登録日
最初に提出
2017年11月18日
QC基準を満たした最初の提出物
2017年12月4日
最初の投稿 (実際)
2017年12月11日
学習記録の更新
投稿された最後の更新 (実際)
2017年12月11日
QC基準を満たした最後の更新が送信されました
2017年12月4日
最終確認日
2017年11月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- RNI2017/FLUVALENTINE-BAUX/YB
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。