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Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus (FLUVALENTINE)

4 декабря 2017 г. обновлено: 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

Обзор исследования

Статус

Неизвестный

Условия

Тип исследования

Наблюдательный

Регистрация (Ожидаемый)

35

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Франция
      • Nancy, Франция, 54000
        • Рекрутинг
        • Baux
        • Контакт:
          • Elisabeth Baux, MD
          • Номер телефона: +33 03 83 15 28 65
          • Электронная почта: e.baux@chru-nancy.fr

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

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.

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of dead patients
Временное ограничение: 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)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Demographic data relating to age
Временное ограничение: Baseline
age
Baseline
Demographic data relating to sex
Временное ограничение: Baseline
sex
Baseline
Respiratory failure
Временное ограничение: Baseline
PaO2/iFO2 value
Baseline
Demographic data relating to immunosuppression
Временное ограничение: Baseline
Amount of polynuclear neutrophils (G/L)
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Временное ограничение: Baseline
hospitalization
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Временное ограничение: Baseline
dialysis
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Временное ограничение: Baseline
surgery
Baseline
risk factors for methicillin-resistant Staphylococcus aureus
Временное ограничение: Baseline
presence of percutaneous or long-term catheter
Baseline
Clinical data relating to pre-admission antibiotics
Временное ограничение: Baseline
type of antibiotic prescribed
Baseline
Clinical data in the initial phase relating to SAPS 2 score
Временное ограничение: 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
Временное ограничение: Baseline
Sequential Organ Failure Assessment (SOFA)
Baseline
Clinical data in the initial phase relating to neutropenia
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Central Hospital, Nancy, France

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 октября 2017 г.

Первичное завершение (Действительный)

20 октября 2017 г.

Завершение исследования (Ожидаемый)

1 марта 2018 г.

Даты регистрации исследования

Первый отправленный

18 ноября 2017 г.

Впервые представлено, что соответствует критериям контроля качества

4 декабря 2017 г.

Первый опубликованный (Действительный)

11 декабря 2017 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

11 декабря 2017 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

4 декабря 2017 г.

Последняя проверка

1 ноября 2017 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • RNI2017/FLUVALENTINE-BAUX/YB

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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