Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
15 de novembro de 2007 atualizado por: Eli Lilly and Company
The purposes of this study are to determine:
- Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated).
- Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.
- The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
The primary objective was to demonstrate that drotrecogin alfa (activated) compared with placebo reduced severe-sepsis-induced organ dysfunction as assessed by time to complete resolution of a composite of cardiovascular, respiratory, and renal organ failure in pediatric patients with severe sepsis.
Secondary objectives included: (1) to assess whether treatment with drotrecogin alfa (activated) reduced 28-day all-cause mortality in pediatric patients with severe sepsis compared with placebo patients, (2) to evaluate the effects of drotrecogin alfa (activated) on individual organ dysfunction (cardiovascular, respiratory, renal, hepatic, hematologic, neurologic, and cutaneous), (3) to demonstrate that drotrecogin alfa (activated) improved patient outcome as assessed by the Pediatric Overall Performance Category (POPC) scale, (4) to demonstrate that drotrecogin alfa (activated) reduced major amputations (at or above the wrist, at or above the ankle, face, and genitals) in pediatric patients with Neisseria meningitidis (proven or suspected) and/or purpura fulminans, (5) to demonstrate that drotrecogin alfa (activated) had antithrombotic and anti-inflammatory properties. The safety objective was to evaluate whether drotrecogin alfa (activated) had an acceptable safety profile when administered to pediatric patients with severe sepsis.
Tipo de estudo
Intervencional
Inscrição (Real)
474
Estágio
- Fase 3
Contactos e Locais
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Locais de estudo
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Erlangen, Alemanha
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Magdeburg, Alemanha
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Wurzburg, Alemanha
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New South Wales
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Westmead, New South Wales, Austrália
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Tasmania
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Hobart, Tasmania, Austrália
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Santiago de Chile, Chile
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Bratislava, Eslováquia
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Bystrica
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Banska, Bystrica, Eslováquia
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Alabama
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Birmingham, Alabama, Estados Unidos
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Arizona
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Tucson, Arizona, Estados Unidos
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Tuscon, Arizona, Estados Unidos
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California
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Madera, California, Estados Unidos
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San Diego, California, Estados Unidos
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District of Columbia
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Washington DC, District of Columbia, Estados Unidos
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Idaho
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Boise, Idaho, Estados Unidos
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Illinois
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Chicago, Illinois, Estados Unidos
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Oak Lawn, Illinois, Estados Unidos
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Park Ridge, Illinois, Estados Unidos
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Indiana
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Indianapolis, Indiana, Estados Unidos
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Michigan
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Ann Arbor, Michigan, Estados Unidos
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Missouri
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Kansas City, Missouri, Estados Unidos
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New York
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Albany, New York, Estados Unidos
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New Hyde Park, New York, Estados Unidos
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New York, New York, Estados Unidos
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos
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Pittsburgh, Pennsylvania, Estados Unidos
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South Carolina
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Charleston, South Carolina, Estados Unidos
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Tennessee
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Nashville, Tennessee, Estados Unidos
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Texas
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San Antonio, Texas, Estados Unidos
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Virginia
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Falls Church, Virginia, Estados Unidos
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Amiens, França
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Amiens Cedex, França
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Bordeaux, França
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Le Kremlin-Bicetre, França
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Lyon, França
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Lyon Cedex 03, França
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Marseille, França
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Nantes, França
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Toulouse, França
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Milano, Itália
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Benito Juarez
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Mexico City, Benito Juarez, México
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Lublin, Polônia
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Birmingham, Reino Unido
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London, Reino Unido
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Manchester, Reino Unido
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Southhampton, Reino Unido
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Hants
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Southhampton, Hants, Reino Unido
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London
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Bloomsbury, London, Reino Unido
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Paddington, London, Reino Unido
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Zurich, Suíça
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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
Não mais velho que 17 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Suspected or proven acute infection.
- Abnormally high or low core body temperature
- Cardiovascular dysfunction which requires the use of vasoactive drugs (such as, dopamine, dobutamine, epinephrine) and is the result of severe sepsis.
- Respiratory dysfunction which requires the use of mechanical ventilation and is the result of severe sepsis.
Exclusion Criteria:
- Patients at increased risk of bleeding.
- Patients at high risk for an intracranial bleed.
- Patients who have undergone a bone marrow transplant.
- Patients with end-stage renal disease.
- Patients whose family or primary care physician is unwilling to allow transfusion of blood products.
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
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 1
24 microgramas/kg/h durante 96 horas (+ ou - 1 hora)
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Outros nomes:
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Comparador de Placebo: 2
0,9% cloreto de sódio
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
Prazo: 3 Years
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3 Years
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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All cause mortality data
Prazo: 3 Years
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3 Years
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The effects of drotrecogin alfa (activated) on individual organ dysfunction
Prazo: 3 Years
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3 Years
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Amputation reduction (at or above the wrist, at or above the ankle, face, and genitals)in pediatric patients with Neisseria meningitidis
Prazo: 3 Years
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3 Years
|
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Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.
Prazo: 3 Years
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3 Years
|
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
- Farris RW, Weiss NS, Zimmerman JJ. Functional outcomes in pediatric severe sepsis: further analysis of the researching severe sepsis and organ dysfunction in children: a global perspective trial. Pediatr Crit Care Med. 2013 Nov;14(9):835-42. doi: 10.1097/PCC.0b013e3182a551c8.
- Nadel S, Goldstein B, Williams MD, Dalton H, Peters M, Macias WL, Abd-Allah SA, Levy H, Angle R, Wang D, Sundin DP, Giroir B; REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective (RESOLVE) study group. Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial. Lancet. 2007 Mar 10;369(9564):836-843. doi: 10.1016/S0140-6736(07)60411-5.
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 novembro de 2002
Conclusão do estudo (Real)
1 de abril de 2005
Datas de inscrição no estudo
Enviado pela primeira vez
13 de novembro de 2002
Enviado pela primeira vez que atendeu aos critérios de CQ
13 de novembro de 2002
Primeira postagem (Estimativa)
14 de novembro de 2002
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
20 de novembro de 2007
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de novembro de 2007
Última verificação
1 de novembro de 2007
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 6716
- F1K-MC-EVBP
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 .