- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00049764
Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Erlangen, Alemania
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Magdeburg, Alemania
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Wurzburg, Alemania
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New South Wales
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Westmead, New South Wales, Australia
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Tasmania
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Hobart, Tasmania, Australia
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Santiago de Chile, Chile
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Bratislava, Eslovaquia
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Bystrica
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Banska, Bystrica, Eslovaquia
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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, Francia
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Amiens Cedex, Francia
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Bordeaux, Francia
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Le Kremlin-Bicetre, Francia
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Lyon, Francia
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Lyon Cedex 03, Francia
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Marseille, Francia
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Nantes, Francia
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Toulouse, Francia
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Milano, Italia
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Benito Juarez
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Mexico City, Benito Juarez, México
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Lublin, Polonia
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Birmingham, Reino Unido
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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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, Suiza
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 1
24 microgramos/kg/h durante 96 horas (+ o - 1 hora)
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Otros nombres:
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Comparador de placebos: 2
Cloruro de sodio al 0,9 %
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
Periodo de tiempo: 3 Years
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3 Years
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
All cause mortality data
Periodo de tiempo: 3 Years
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3 Years
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The effects of drotrecogin alfa (activated) on individual organ dysfunction
Periodo de tiempo: 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
Periodo de tiempo: 3 Years
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3 Years
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Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.
Periodo de tiempo: 3 Years
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3 Years
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 6716
- F1K-MC-EVBP
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Septicemia
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University of Kansas Medical CenterUniversity of KansasReclutamientoSepticemia | Shock séptico | Síndrome de sepsis | Sepsis, Severa | Sepsis bacteriana | Sepsis BacteriemiaEstados Unidos
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Jip GroenInBiomeReclutamientoColonización Microbiana | Infeccion Neonatal | Sepsis Neonatal, Inicio Temprano | Enfermedad microbiana | Sepsis clínica | Sepsis neonatal con cultivo negativo | Sepsis Neonatal, Inicio Tardío | Sepsis neonatal con cultivo positivoPaíses Bajos
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Indonesia UniversityTerminadoImpacto del tratamiento con heparina no fraccionada en dosis bajas sobre la inflamación en la sepsisSepsis severa con shock séptico | Sepsis severa sin shock sépticoIndonesia
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Ohio State UniversityTerminadoSepsis, Sepsis Severa y Shock SépticoEstados Unidos
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Yale UniversityRetiradoSepsis Neonatal de Inicio Temprano | Sepsis neonatal de inicio tardíoEstados Unidos
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The University of QueenslandRoyal Brisbane and Women's HospitalDesconocido
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University of LeicesterUniversity Hospitals, Leicester; The Royal College of AnaesthetistsTerminadoSepticemia | Shock séptico | Sepsis severa | Síndrome de sepsisReino Unido
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Karolinska InstitutetÖrebro University, SwedenTerminadoSepticemia | Síndrome de sepsis | Sepsis, SeveraSuecia
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Weill Medical College of Cornell UniversityNational Heart, Lung, and Blood Institute (NHLBI); New York Presbyterian Hospital y otros colaboradoresTerminadoSepticemia | Shock séptico | Sepsis severa | Infección | Síndrome de sepsisEstados Unidos
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Inverness Medical InnovationsTerminadoSepticemia | Síndrome de Respuesta Inflamatoria Sistémica | Sepsis severa | Síndrome de sepsisEstados Unidos