- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01042353
Direct E-test on Bronchoalveolar Lavage From Patients With Ventilator-acquired Pneumonia
Rapid Bacterial Antibiograms Determined by Direct E-test on Bronchoalveolar Lavage From Patients With Ventilator-acquired Pneumonia: a Prospective Comparison With Standard Culture Methods
- Background: Ventilator-acquired pneumonia (VAP) is the most prevalent nosocomial infection in intensive care units (ICUs). Early microbiological diagnosis and initial administration of appropriate antimicrobial therapy are associated with a better outcome. Broad-spectrum antibiotics should therefore be administered initially. However, inconsiderate antibiotic use can increase the prevalence of multi-resistant bacteria.
- Purpose: A rapid antimicrobial susceptibility method is required to decrease the unnecessary use of empirical broad-spectrum antibiotics. The aim of this study is to compare the efficiency of a rapid antibiogram, provided by E-test strips directly applied to bronchoalveolar lavage (BAL) samples and analysed at 24 h, to that obtained with standard methods of culture which provide a later result.
- Study design: This will be an open-label, prospective cohort study of consecutive patients with VAP, conducted in a medical ICU. In addition to standard culture methods, an E-test will be performed directly on BAL samples and analysed at 24 h. Each standard BAL culture will be used as a control for the E-test method.
- Primary outcome: The occurrence of major errors, defined as isolates determined to be susceptible by the E-test but resistant by standard culture methods.
- Secondary outcomes: The occurrence of minor errors (defined as isolates determined to be resistant by the E-test and susceptible by the standard method), and a comparison of two methods of seeding BAL samples on Mueller Hinton agar plates (swabbing method, flooding method).
Eligibility criteria:
- Inclusion criteria: all patients with suspected VAP (defined by a Clinical Pulmonary Infection Score ≥5) undergoing BAL will be eligible.
- Exclusion criteria: contraindications for BAL (PaO2/FIO2 <100, risk of bronchoscopy-related haemorrhagic complications), secondary exclusion of patients with negative cultures, defined by a threshold of bacteria <104 CFU/ml.
- Interventions:
BAL samples will be cultured by standard methods and the minimal inhibitory concentration (MIC) of bacteria to the usual antibiotics will be determined using standard procedures. At the time of BAL collection, a rapid antibiogram will be performed by placing E-test antibiotic strips (AB Biodisk) directly onto Mueller-Hinton agar plates seeded with the BAL specimen (both by flooding and swabbing). E-test strips will be impregnated with cefoxitin, piperacillin-tazobactam, cefepime, imipenem, ciprofloxacin and amikacin. At 24 h, the E-test plates will be photographed and then examined separately by both a bacteriologist and a medical ICU physician following a consensus method. The final E-test results will be compared with the standard MIC cultures.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Fase 4
Contactos e Locais
Locais de estudo
-
-
-
Bordeaux, França, 33000
- CHU Bordeaux
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- all patients with suspected VAP (defined by a Clinical Pulmonary Infection Score ≥5) undergoing BAL will be eligible.
Exclusion Criteria:
- contraindications for BAL (PaO2/FIO2 <100, risk of bronchoscopy-related haemorrhagic complications), secondary exclusion of patients with negative cultures, defined by a threshold of bacteria <104 CFU/ml.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: E test
|
At the time of BAL collection, a rapid antibiogram will be performed by placing E-test antibiotic strips (AB Biodisk) directly onto Mueller-Hinton agar plates seeded with the BAL specimen (both by flooding and swabbing).
E-test strips will be impregnated with cefoxitin, piperacillin-tazobactam, cefepime, imipenem, ciprofloxacin and amikacin.
At 24 h, the E-test plates will be photographed and then examined separately by both a bacteriologist and a medical ICU physician following a consensus method.
The final E-test results will be compared with the standard MIC cultures.
|
Comparador Ativo: standard culture method
|
BAL samples will be cultured by standard methods and the minimal inhibitory concentration (MIC) of bacteria to the usual antibiotics will be determined using standard procedures
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
---|
The occurrence of major errors, defined as isolates determined to be susceptible by the E-test but resistant by standard culture methods.
|
Medidas de resultados secundários
Medida de resultado |
---|
The occurrence of minor errors (defined as isolates determined to be resistant by the E-test and susceptible by the standard method), and a comparison of two methods of seeding BAL samples on Mueller Hinton agar plates (swabbing method, flooding method).
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: alexandre Boyer, MD, Université Bordeaux 2
Publicações e links úteis
Datas de registro do estudo
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CHU BDX réa med
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 .
Ensaios clínicos em E test
-
Istinye UniversityInscrevendo-se por conviteDerrame | Teleavaliação | O teste Timed Up & Go | Teste de levantar da cadeira de 30 segundosPeru
-
Assistance Publique - Hôpitaux de ParisDesconhecidoVentilação mecânicaFrança
-
Kenya Medical Research InstituteFoundation for Innovative New Diagnostics (FIND)Desconhecido
-
hearX GroupUniversity of PretoriaConcluído
-
Tel-Aviv Sourasky Medical CenterDesconhecidoPerda auditiva neurossensorial súbita
-
Drägerwerk AG & Co. KGaARescindido
-
University Hospital, BordeauxDesconhecido
-
PepsiCo Global R&DConcluído
-
AllerdermConcluídoDermatite de contatoDinamarca, Estados Unidos
-
Ufuk UniversityConcluído