Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
15 novembre 2007 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Effettivo)
474
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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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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Amiens, Francia
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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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Erlangen, Germania
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Magdeburg, Germania
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Wurzburg, Germania
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Milano, Italia
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Benito Juarez
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Mexico City, Benito Juarez, Messico
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Lublin, Polonia
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Birmingham, Regno Unito
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London, Regno Unito
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Manchester, Regno Unito
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Southhampton, Regno Unito
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Hants
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Southhampton, Hants, Regno Unito
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London
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Bloomsbury, London, Regno Unito
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Paddington, London, Regno Unito
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Bratislava, Slovacchia
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Bystrica
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Banska, Bystrica, Slovacchia
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Alabama
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Birmingham, Alabama, Stati Uniti
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Arizona
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Tucson, Arizona, Stati Uniti
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Tuscon, Arizona, Stati Uniti
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California
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Madera, California, Stati Uniti
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San Diego, California, Stati Uniti
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District of Columbia
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Washington DC, District of Columbia, Stati Uniti
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Idaho
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Boise, Idaho, Stati Uniti
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Illinois
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Chicago, Illinois, Stati Uniti
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Oak Lawn, Illinois, Stati Uniti
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Park Ridge, Illinois, Stati Uniti
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Indiana
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Indianapolis, Indiana, Stati Uniti
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Michigan
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Ann Arbor, Michigan, Stati Uniti
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Missouri
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Kansas City, Missouri, Stati Uniti
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New York
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Albany, New York, Stati Uniti
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New Hyde Park, New York, Stati Uniti
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New York, New York, Stati Uniti
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti
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Pennsylvania
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Hershey, Pennsylvania, Stati Uniti
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Pittsburgh, Pennsylvania, Stati Uniti
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South Carolina
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Charleston, South Carolina, Stati Uniti
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Tennessee
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Nashville, Tennessee, Stati Uniti
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Texas
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San Antonio, Texas, Stati Uniti
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Virginia
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Falls Church, Virginia, Stati Uniti
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Zurich, Svizzera
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Non più vecchio di 17 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 1
24 microgrammi/kg/ora per 96 ore (+ o - 1 ora)
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Altri nomi:
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Comparatore placebo: 2
Cloruro di sodio allo 0,9%.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
Lasso di tempo: 3 Years
|
3 Years
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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All cause mortality data
Lasso di tempo: 3 Years
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3 Years
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The effects of drotrecogin alfa (activated) on individual organ dysfunction
Lasso di tempo: 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
Lasso di tempo: 3 Years
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3 Years
|
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Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.
Lasso di tempo: 3 Years
|
3 Years
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2002
Completamento dello studio (Effettivo)
1 aprile 2005
Date di iscrizione allo studio
Primo inviato
13 novembre 2002
Primo inviato che soddisfa i criteri di controllo qualità
13 novembre 2002
Primo Inserito (Stima)
14 novembre 2002
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
20 novembre 2007
Ultimo aggiornamento inviato che soddisfa i criteri QC
15 novembre 2007
Ultimo verificato
1 novembre 2007
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 6716
- F1K-MC-EVBP
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .