- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Erlangen, Allemagne
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Magdeburg, Allemagne
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Wurzburg, Allemagne
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New South Wales
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Westmead, New South Wales, Australie
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Tasmania
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Hobart, Tasmania, Australie
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Santiago de Chile, Chili
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Amiens, France
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Amiens Cedex, France
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Bordeaux, France
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Le Kremlin-Bicetre, France
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Lyon, France
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Lyon Cedex 03, France
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Marseille, France
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Nantes, France
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Toulouse, France
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Milano, Italie
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Benito Juarez
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Mexico City, Benito Juarez, Mexique
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Lublin, Pologne
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Birmingham, Royaume-Uni
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London, Royaume-Uni
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Manchester, Royaume-Uni
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Southhampton, Royaume-Uni
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Hants
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Southhampton, Hants, Royaume-Uni
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London
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Bloomsbury, London, Royaume-Uni
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Paddington, London, Royaume-Uni
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Bratislava, Slovaquie
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Bystrica
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Banska, Bystrica, Slovaquie
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Zurich, Suisse
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Alabama
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Birmingham, Alabama, États-Unis
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Arizona
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Tucson, Arizona, États-Unis
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Tuscon, Arizona, États-Unis
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California
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Madera, California, États-Unis
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San Diego, California, États-Unis
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District of Columbia
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Washington DC, District of Columbia, États-Unis
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Idaho
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Boise, Idaho, États-Unis
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Illinois
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Chicago, Illinois, États-Unis
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Oak Lawn, Illinois, États-Unis
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Park Ridge, Illinois, États-Unis
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Indiana
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Indianapolis, Indiana, États-Unis
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Michigan
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Ann Arbor, Michigan, États-Unis
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Missouri
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Kansas City, Missouri, États-Unis
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New York
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Albany, New York, États-Unis
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New Hyde Park, New York, États-Unis
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New York, New York, États-Unis
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis
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Pennsylvania
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Hershey, Pennsylvania, États-Unis
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Pittsburgh, Pennsylvania, États-Unis
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South Carolina
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Charleston, South Carolina, États-Unis
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Tennessee
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Nashville, Tennessee, États-Unis
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Texas
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San Antonio, Texas, États-Unis
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Virginia
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Falls Church, Virginia, États-Unis
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 1
24 microgrammes/kg/h pendant 96 heures (+ ou - 1 heure)
|
Autres noms:
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Comparateur placebo: 2
0,9 % de chlorure de sodium
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
Délai: 3 Years
|
3 Years
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
All cause mortality data
Délai: 3 Years
|
3 Years
|
The effects of drotrecogin alfa (activated) on individual organ dysfunction
Délai: 3 Years
|
3 Years
|
Amputation reduction (at or above the wrist, at or above the ankle, face, and genitals)in pediatric patients with Neisseria meningitidis
Délai: 3 Years
|
3 Years
|
Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.
Délai: 3 Years
|
3 Years
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 6716
- F1K-MC-EVBP
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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