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Data Collection and Identification of Infection-responsible Bacterial Resistances in Cirrhotic Patients (RECONNAISSANCE)

18 de março de 2022 atualizado por: Hospices Civils de Lyon

Cirrhotic patients have a high risk of bacterial infection. These infections induce systemic inflammation that can lead to acute liver failure or even acute liver failure associated with multi-visceral failure (Acute-to-Chronic Liver Failure, ACLF) associated with an increased risk of short-term mortality in this population.

The most common infections are spontaneous bacterial peritonitis and urinary tract infections, followed by pneumonia, skin and soft tissue infections and spontaneous bacteremia.

In order to cope with the growing risk of resistant bacterial infections, recommendations from the European Association for the Study of the Liver (EASL) were issued in 2014 and are followed by physicians treating cirrhotic patients. These recommendations advocate taking into account different parameters regarding the best therapeutic strategy to adopt. The site of the infection, the mode of acquisition or the presence or absence of prophylaxis may modify this therapeutic approach to infections of cirrhotic patients to a greater or lesser extent. However, the ecology of a center varies over time, according to the practices of the hospital center and to the different patients in care. It is recommended to update the antibiotic resistance data in order to propose the best therapeutic strategy for these patients.

The study of bacterial resistance in a given care center makes it possible to adapt the recommendations published by EASL in 2014 to the local ecology and to set up protocols of probabilistic antibiotic therapy adapted for a better efficiency.

This descriptive cohort study will determine the local ecology of the center. This will enable the center to assess if the recommended antibacterial strategies correspond to the center bacterial ecology.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

Cirrhotic patients have a high risk of bacterial infection. These infections induce systemic inflammation that can lead to acute liver failure or even acute liver failure associated with multi-visceral failure (Acute-to-Chronic Liver Failure, ACLF) associated with an increased risk of short-term mortality in this population.

Cirrhotic patients have a higher risk of infection than the general population because cirrhosis is associated with various changes in the innate and acquired immune response. These changes alter the response to external pathogens, leading to some immunodeficiency (3). Infection is one of the most common risk factors for ACLF and the prevalence of bacterial infections is approximately 25% -46% in hospitalized patients with acute liver decompensation.

The most common infections are spontaneous bacterial peritonitis and urinary tract infections, followed by pneumonia, skin and soft tissue infections and spontaneous bacteremia.

These infections can have various etiologies. The site of infection and the mode of acquisition may affect the risk of infection with resistant bacteria. The increasing diffusion of multidrug-resistant bacteria has made the management of cirrhotic patients and bacterial infections more complex.

Early administration of effective antibiotic therapy is crucial for determining the patient's prognosis. This empirical treatment should be initiated at the earliest after diagnosis of the bacterial infection to avoid an increased mortality risk due to possible septic shock or associated multi-visceral failure (ACLF). The antibiotic treatment administered takes into account the type of infection, the risk of resistant bacterial infection but also the severity of the infection. However, this antibiotic administration can also select multi-resistant bacteria and increase the risk of mortality of the cirrhotic patient.

In order to cope with the growing risk of resistant bacterial infections, recommendations from the European Association for the Study of the Liver (EASL) were issued in 2014 and are followed by physicians treating cirrhotic patients. These recommendations advocate taking into account different parameters regarding the best therapeutic strategy to adopt. The site of the infection, the mode of acquisition or the presence or absence of prophylaxis may modify this therapeutic approach to infections of cirrhotic patients to a greater or lesser extent. However, the ecology of a center varies over time, according to the practices of the hospital center and to the different patients in care. It is recommended to update the antibiotic resistance data in order to propose the best therapeutic strategy for these patients.

The study of bacterial resistance in a given care center makes it possible to adapt the recommendations published by EASL in 2014 to the local ecology and to set up protocols of probabilistic antibiotic therapy adapted for a better efficiency.

This descriptive cohort study will determine the local ecology of the center. This will enable the center to assess if the recommended antibacterial strategies correspond to the center bacterial ecology.

Tipo de estudo

Observacional

Inscrição (Real)

71

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

      • Lyon, França, 69004
        • Croix-Rousse Hospital, Hospices Civils de Lyon

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

Bacteria-infected cirrhotic patients

Descrição

Inclusion Criteria:

  • Women and men ≥18 years of age
  • Cirrhosis diagnosis confirmed with a Doppler and/or a biopsy
  • bacterial infection documented with identified germ and susceptibility results
  • patient informed and non-opposed to participate

Exclusion Criteria:

  • cirrhotic patients with another infection than bacterial infection
  • legally protected patients
  • patients who expressed their opposition to participate to the study

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

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
Bacteria-infected cirrhotic patients
All kind of etiologies for cirrhosis and all kind of bacterial infections (spontaneous bacterial peritonitis, urinary tract infections, pneumonia, skin and soft tissue infections and spontaneous bacteremia)

For each cirrhotic patient hospitalized for a bacterial infection, a blood sample or a peritoneal liquid sample was collected and analyzed for susceptibility, as it is performed in the standard of care. Our department receives only the bacterial results.

We will then describe the bacterial ecology of the center cirrhotic population in terms of infection acquisition mode, infection site, infection etiology but also drug-resistance.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Bacterial results
Prazo: At inclusion
A cirrhotic patient can have several sampling for bacterial analysis. Blood or peritoneal liquid samples are analyzed to identify the ecology of cirrhotic patients in the center. These bacteria will be described in terms of acquisition mode, infection site and drug-resistance.
At inclusion

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

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 novembro de 2018

Conclusão Primária (Real)

31 de janeiro de 2020

Conclusão do estudo (Real)

31 de março de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

23 de maio de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de maio de 2019

Primeira postagem (Real)

29 de maio de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de março de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de março de 2022

Última verificação

1 de março de 2022

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CRC_GHN_2019_005

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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