Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus (FLUVALENTINE)
4 de diciembre de 2017 actualizado por: 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
Descripción general del estudio
Estado
Desconocido
Condiciones
Tipo de estudio
De observación
Inscripción (Anticipado)
35
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Nancy, Francia, 54000
- Reclutamiento
- Baux
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Contacto:
- Elisabeth Baux, MD
- Número de teléfono: +33 03 83 15 28 65
- Correo electrónico: e.baux@chru-nancy.fr
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of dead patients
Periodo de tiempo: During Length of stay in intensive care unit (an average of 2 weeks)
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All cause of mortality
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Demographic data relating to age
Periodo de tiempo: Baseline
|
age
|
Baseline
|
|
Demographic data relating to sex
Periodo de tiempo: Baseline
|
sex
|
Baseline
|
|
Respiratory failure
Periodo de tiempo: Baseline
|
PaO2/iFO2 value
|
Baseline
|
|
Demographic data relating to immunosuppression
Periodo de tiempo: Baseline
|
Amount of polynuclear neutrophils (G/L)
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Periodo de tiempo: Baseline
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hospitalization
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Periodo de tiempo: Baseline
|
dialysis
|
Baseline
|
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risk factors for methicillin-resistant Staphylococcus aureus
Periodo de tiempo: Baseline
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surgery
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Periodo de tiempo: Baseline
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presence of percutaneous or long-term catheter
|
Baseline
|
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Clinical data relating to pre-admission antibiotics
Periodo de tiempo: Baseline
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type of antibiotic prescribed
|
Baseline
|
|
Clinical data in the initial phase relating to SAPS 2 score
Periodo de tiempo: 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
Periodo de tiempo: Baseline
|
Sequential Organ Failure Assessment (SOFA)
|
Baseline
|
|
Clinical data in the initial phase relating to neutropenia
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
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Clinical data in the initial phase relating to productive cough
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: During Length of stay in intensive care unit (an average of 2 weeks)
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renal failure according to KDIGO classification
|
During Length of stay in intensive care unit (an average of 2 weeks)
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Prognostic factors for this pathology
Periodo de tiempo: 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
Periodo de tiempo: 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)
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|
Collection of infectious samples
Periodo de tiempo: 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
Periodo de tiempo: 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)
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|
Probabilistic antibiotherapy
Periodo de tiempo: 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)
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|
Prescribed antibiotic therapy
Periodo de tiempo: 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
Periodo de tiempo: 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)
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|
Collection of the date of introduction of adapted antibiotic therapy
Periodo de tiempo: 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)
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|
Number of patients with Influenza type A
Periodo de tiempo: During Length of stay in intensive care unit (an average of 2 weeks)
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Number of patients with Influenza type A
|
During Length of stay in intensive care unit (an average of 2 weeks)
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|
Number of patients with Influenza type B
Periodo de tiempo: During Length of stay in intensive care unit (an average of 2 weeks)
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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
Periodo de tiempo: During Length of stay in intensive care unit (an average of 2 weeks)
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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
Periodo de tiempo: 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)
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|
Number of serious influenza infections per year and per center with early and late deaths
Periodo de tiempo: During Length of stay in intensive care unit (an average of 2 weeks)
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Mortality caused by serious inflenza infections
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de octubre de 2017
Finalización primaria (Actual)
20 de octubre de 2017
Finalización del estudio (Anticipado)
1 de marzo de 2018
Fechas de registro del estudio
Enviado por primera vez
18 de noviembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
4 de diciembre de 2017
Publicado por primera vez (Actual)
11 de diciembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de diciembre de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
4 de diciembre de 2017
Última verificación
1 de noviembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones por virus de ARN
- Enfermedades virales
- Infecciones
- Infecciones del Tracto Respiratorio
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Infecciones por bacterias grampositivas
- Infecciones por Orthomyxoviridae
- Neumonía
- Influenza Humana
- Neumonía Bacteriana
- Infecciones estafilocócicas
- Neumonía Estafilocócica
Otros números de identificación del estudio
- RNI2017/FLUVALENTINE-BAUX/YB
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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