Epidemiology of Post-influenza Bacterial Pneumonia Due to a Panton-Valentine Leukocidin Positive Staphylococcus Aureus (FLUVALENTINE)
4 de dezembro de 2017 atualizado 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
Visão geral do estudo
Status
Desconhecido
Tipo de estudo
Observacional
Inscrição (Antecipado)
35
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Nancy, França, 54000
- Recrutamento
- Baux
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Contato:
- Elisabeth Baux, MD
- Número de telefone: +33 03 83 15 28 65
- E-mail: e.baux@chru-nancy.fr
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of dead patients
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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All cause of mortality
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During Length of stay in intensive care unit (an average of 2 weeks)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Demographic data relating to age
Prazo: Baseline
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age
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Baseline
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Demographic data relating to sex
Prazo: Baseline
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sex
|
Baseline
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Respiratory failure
Prazo: Baseline
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PaO2/iFO2 value
|
Baseline
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|
Demographic data relating to immunosuppression
Prazo: Baseline
|
Amount of polynuclear neutrophils (G/L)
|
Baseline
|
|
risk factors for methicillin-resistant Staphylococcus aureus
Prazo: Baseline
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hospitalization
|
Baseline
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risk factors for methicillin-resistant Staphylococcus aureus
Prazo: Baseline
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dialysis
|
Baseline
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risk factors for methicillin-resistant Staphylococcus aureus
Prazo: Baseline
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surgery
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Baseline
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risk factors for methicillin-resistant Staphylococcus aureus
Prazo: Baseline
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presence of percutaneous or long-term catheter
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Baseline
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Clinical data relating to pre-admission antibiotics
Prazo: Baseline
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type of antibiotic prescribed
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Baseline
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|
Clinical data in the initial phase relating to SAPS 2 score
Prazo: Baseline
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Simplified acute Physiology score (SAPS2) score between 0 and 163 and a predicted mortality between 0% and 100%
|
Baseline
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|
Clinical data in the initial phase relating to SOFA admission
Prazo: Baseline
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Sequential Organ Failure Assessment (SOFA)
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Baseline
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|
Clinical data in the initial phase relating to neutropenia
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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neutropenia
|
During Length of stay in intensive care unit (an average of 2 weeks)
|
|
Clinical data in the initial phase relating to neutropenia
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
|
thrombocytopenia
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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 metabolic acidosis
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
|
metabolic acidosis
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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 oxygen dependence
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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oxygen dependence
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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 hyperthermia
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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hyperthermia
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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 chills
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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chills
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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 headhache
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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headache
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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 productive cough
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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productive cough
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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 dyspnoea
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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dyspnoea
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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 acute respiratory failure
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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acute respiratory failure
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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 hemoptysis
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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hemoptysis
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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 uni - or multi - lobar infiltration on chest X - ray or CT scan
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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renal failure according to KDIGO classification
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During Length of stay in intensive care unit (an average of 2 weeks)
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Prognostic factors for this pathology
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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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
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During Length of stay in intensive care unit (an average of 2 weeks)
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Complications
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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Duration of probabilistic antibiotherapy
|
During Length of stay in intensive care unit (an average of 2 weeks)
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|
Prescribed antibiotic therapy
Prazo: 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)
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|
Prescribed antibiotic therapy
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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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
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
|
Collection of the date of introduction of adapted antibiotic therapy
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During Length of stay in intensive care unit (an average of 2 weeks)
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|
Number of patients with Influenza type A
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
|
Number of patients with Influenza type A
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During Length of stay in intensive care unit (an average of 2 weeks)
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Number of patients with Influenza type B
Prazo: 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)
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|
Date of initiation of anti-viral treatment in relation to the onset of symptoms and duration of anti-viral treatment
Prazo: 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)
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Dosage of antiviral treatment
Prazo: During Length of stay in intensive care unit (an average of 2 weeks)
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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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de outubro de 2017
Conclusão Primária (Real)
20 de outubro de 2017
Conclusão do estudo (Antecipado)
1 de março de 2018
Datas de inscrição no estudo
Enviado pela primeira vez
18 de novembro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de dezembro de 2017
Primeira postagem (Real)
11 de dezembro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
11 de dezembro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de dezembro de 2017
Última verificação
1 de novembro de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Infecções por vírus de RNA
- Doenças Virais
- Infecções
- Infecções do Trato Respiratório
- Doenças Respiratórias
- Doenças pulmonares
- Infecções bacterianas
- Infecções Bacterianas e Micoses
- Infecções por Bactérias Gram-Positivas
- Infecções por Orthomyxoviridae
- Pneumonia
- Gripe Humana
- Pneumonia Bacteriana
- Infecções Estafilocócicas
- Pneumonia Estafilocócica
Outros números de identificação do estudo
- RNI2017/FLUVALENTINE-BAUX/YB
Informações sobre medicamentos e dispositivos, documentos de estudo
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Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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