French Study In ICU Patients Treated With Tigecycline
15 de novembro de 2011 atualizado por: Wyeth is now a wholly owned subsidiary of Pfizer
French Prospective Observational Study In Intensive Care Unit (ICU) Patients Treated With Tigecycline
This study will describe clinical outcome and safety data collected prospectively in subjects hospitalized in an intensive care unit (ICU) presenting with an infection for which treatment with tigecycline, alone or in combination, is planned.
Data will be collected only from subjects providing informed consent.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Healthcare visit.
Extension Rationale:
In order to perform the necessary corrective actions required and to secure database consistency, we request an extension for posting of Basic Results due 26-May-2011 for protocol 3074A1-4448 (B1811030), NCT00799591. Our proposed submission date is 14-Sept-2011.
Pfizer acquired Wyeth on October 16, 2009. With regard to this study, our reconciliation of data identified some discrepancies in data listed in the Project database (managed by the CRO) and the Safety Database (managed by Pfizer). We are taking corrective action which involves: sending queries to investigators, collecting corrective signed forms, and implementing changes within the database. We are requesting this extension to complete that work so that the data can be treated as final and the CSR can be completed.
Tipo de estudo
Observacional
Inscrição (Real)
156
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
-
-
-
Paris, França, 75018
- Pfizer Investigational Site
-
-
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
Intensive Care Unit
Descrição
Inclusion Criteria:
- Adult men and women (18 years).
- Subjects hospitalized in a medical or surgical intensive care unit (ICU) (on the day of enrolment in the study).
- Subjects treated with tigecycline (first, second or third line), said treatment freely chosen by the participating physician, prior to enrollment in the study.
Exclusion Criteria:
- Subjects participating in another biomedical research study.
- Patient (or legal representative) who has not dated or signed informed consent document.
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
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
1
Intensive Care
|
Observational study so no intervention in the patient.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at End of Treatment (EOT)
Prazo: End of Treatment (on the day of last dose of study treatment) or up to 25 months
|
Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event.
Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.
|
End of Treatment (on the day of last dose of study treatment) or up to 25 months
|
|
Percentage of Participants Per Clinical Outcome (Success, Failure, or Undetermined) at Follow-up Visit
Prazo: Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
|
Clinical Success: lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
Failure: persistence of initial infection (required change of antibiotic or surgery), death related to infection (>48 hours after start of treatment with tigecycline), or premature cessation of treatment due to treatment-related Adverse Event.
Undetermined: insufficient data for assessment, death not directly related to initial infection, death within first 48 hours of start of treatment with tigecycline, or additional antibiotic treatment for other than initial infection.
|
Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Participants Per Tigecycline Loading Dose and Maintenance Dose
Prazo: Baseline (Inclusion) through last dose of study treatment or up to 25 months
|
Tigecycline powder for solution 50 milligrams (mg) for intravenous (IV) infusion could be administered with an initial loading dose of 100 mg followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity.
|
Baseline (Inclusion) through last dose of study treatment or up to 25 months
|
|
Mean Duration (Days) of Treatment With Tigecycline
Prazo: Baseline (Inclusion) through last dose of study treatment or up to 25 months
|
Baseline (Inclusion) through last dose of study treatment or up to 25 months
|
|
|
Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at EOT
Prazo: Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months
|
Combinations of antibiotic treatments for participants treated with clinical success with tigecycline.
Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
|
Baseline (Inclusion), End of Treatment (on the day of last dose of study treatment) or up to 25 months
|
|
Percentage of Participants (> 10%) With Use of Other Antibiotics in Combination With Tigecycline Who Had Clinical Success at Follow-up Visit
Prazo: Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
|
Combinations of antibiotic treatments for participants treated with clinical success with tigecycline.
Clinical success defined as lack of need to use new antibiotic or a surgical treatment not initially planned for initial infection.
|
Baseline (Inclusion), Follow-up Visit (7 days after last dose or at hospital discharge whichever occurred within 7 days after last dose) or up to 25 months
|
|
Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Positive Blood Culture
Prazo: Post-baseline (Day 1) through last dose of study treatment or up to 25 months
|
Microbiological sampling results categorized as a positive blood culture (presence of infection).
|
Post-baseline (Day 1) through last dose of study treatment or up to 25 months
|
|
Percentage of Participants With Microbiological Sampling Results During Treatment Phase With Tigecycline: Direct Examination
Prazo: Post-baseline (Day 1) through last dose of study treatment or up to 25 months
|
Microbiological sampling results categorized according to direct examination (identification of the class of germs).
|
Post-baseline (Day 1) through last dose of study treatment or up to 25 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Bassetti M, Eckmann C, Bodmann KF, Dupont H, Heizmann WR, Montravers P, Guirao X, Capparella MR, Simoneau D, Sanchez Garcia M. Prescription behaviours for tigecycline in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii5-14. doi: 10.1093/jac/dkt140.
- Guirao X, Sanchez Garcia M, Bassetti M, Bodmann KF, Dupont H, Montravers P, Heizmann WR, Capparella MR, Simoneau D, Eckmann C. Safety and tolerability of tigecycline for the treatment of complicated skin and soft-tissue and intra-abdominal infections: an analysis based on five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii37-44. doi: 10.1093/jac/dkt143.
- Montravers P, Bassetti M, Dupont H, Eckmann C, Heizmann WR, Guirao X, Garcia MS, Capparella MR, Simoneau D, Bodmann KF. Efficacy of tigecycline for the treatment of complicated skin and soft-tissue infections in real-life clinical practice from five European observational studies. J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii15-24. doi: 10.1093/jac/dkt141.
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
1 de setembro de 2008
Conclusão Primária (Real)
1 de maio de 2010
Conclusão do estudo (Real)
1 de maio de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
26 de novembro de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de novembro de 2008
Primeira postagem (Estimativa)
1 de dezembro de 2008
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
19 de dezembro de 2011
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de novembro de 2011
Última verificação
1 de setembro de 2011
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 3074A1-4448
- B1811030
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
produto fabricado e exportado dos EUA
Não
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