Undersøgelsen af Drotrecogin Alfa (aktiveret) hos voksne patienter med svær sepsis med lav risiko for død
5. december 2007 opdateret af: Eli Lilly and Company
Effekt og sikkerhed af Drotrecogin Alfa (aktiveret) hos voksne patienter med svær sepsis i et tidligt stadie
Voksne patienter med svær sepsis
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Sammenlignet med placebo reducerer drotrecogin alfa (aktiveret) 28-dages dødelighed af alle årsager hos voksne patienter med svær sepsis med lav risiko for død (for eksempel med en Acute Physiology and Chronic Health Evaluation II (APACHE II) score <25 eller enkelt organdysfunktion).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2640
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Buenos Aires, Argentina
- 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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Ciudad De Buenos Aires, Argentina
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Cordoba, Argentina
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Buenos Aires
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Haedi, Buenos Aires, Argentina
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Monte Grande, Buenos Aires, Argentina
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Rosario - Santa Fe, Buenos Aires, Argentina
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Australian Capital Territory
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Garran, Australian Capital Territory, Australien
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New South Wales
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Camperdown, New South Wales, Australien
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Kingswood, New South Wales, Australien
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Randwick, New South Wales, Australien
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Tasmania
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Hobart, Tasmania, Australien
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Victoria
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Box Hill, Victoria, Australien
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Fitzroy, Victoria, Australien
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Prahan, Victoria, Australien
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Western Australia
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Nedlands, Western Australia, Australien
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Arlon, Belgien
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Brussels, Belgien
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Bruxelles, Belgien
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Gent, Belgien
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Liege, Belgien
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Ottignies, Belgien
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Porto Algre, Brasilien
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Salvador, Brasilien
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PR
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Curitiba, PR, Brasilien
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Rio De Janerio
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Rio de Janeiro, Rio De Janerio, Brasilien
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SC
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Florianopolis, SC, Brasilien
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Sao Paulo
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Sao Jose Rio Preto, Sao Paulo, Brasilien
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Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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British Columbia
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New Westminister, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Nova Scotia
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Halifax, Nova Scotia, Canada
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Ontario
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Brampton, Ontario, Canada
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Kingston, Ontario, Canada
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Ottawa, Ontario, Canada
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Sudbury, Ontario, Canada
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Toronto, Ontario, Canada
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Windsor, Ontario, Canada
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Quebec
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Greenfield Park, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Saskatchewan
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Santiago, Chile
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Santiago
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Las Condes, Santiago, Chile
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Aalborg, Danmark
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Esbjerg, Danmark
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Holbaek, Danmark
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Hvidovre, Danmark
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Roskilde, Danmark
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Sonderborg, Danmark
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Viborg, Danmark
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Copenhagen, S, Danmark
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Cairo, Egypten
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Jyvaskyla, Finland
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Kuopio, Finland
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Oulu, Finland
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Turku, Finland
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Hus
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Helsinki, Hus, Finland
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Argenteuil, Frankrig
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Aulnay-Sous-Bois, Frankrig
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Besancon, Frankrig
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Corbeil Essonnes, Frankrig
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Dijon, Frankrig
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Gleize, Frankrig
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Brno, Tjekkiet
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Hradec Kralove, Tjekkiet
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Olomouc, Tjekkiet
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Plzen, Tjekkiet
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Praha 8, Tjekkiet
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Wein, Østrig
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Innsbuck
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Innsbruck, Innsbuck, Østrig
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Voksne patienter med nylig debut af alvorlig sepsis eller tilstedeværelse af en formodet eller påvist infektion og mindst én induceret organdysfunktion.
Ekskluderingskriterier:
- Er indiceret til behandling med drotrecogin alfa (aktiveret) under den gældende etiket i undersøgelsesstedets land.
- Er kontraindiceret til behandling med drotrecogin alfa (aktiveret) under den gældende etiket i undersøgelsesstedets land.
- Blodpladetal mindre end 30.000/mm3.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 1
24 mikrogram/kg/time i 96 timer (+ eller - 1 time)
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Drotrecogin Alfa (aktiveret)
Andre navne:
|
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Placebo komparator: 2
0,9% natriumchlorid
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0,9% natriumchlorid
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Effektivitet
Tidsramme: 20 måneder
|
20 måneder
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Sikkerhed
Tidsramme: 20 måneder
|
20 måneder
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2002
Studieafslutning (Faktiske)
1. februar 2005
Datoer for studieregistrering
Først indsendt
5. december 2007
Først indsendt, der opfyldte QC-kriterier
5. december 2007
Først opslået (Skøn)
6. december 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
6. december 2007
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. december 2007
Sidst verificeret
1. december 2007
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6669
- F1K-MC-EVCM
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .