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敗血症性ショックの成人患者におけるドロトレコギンアルファ（活性化）の有効性と安全性

2012年8月20日 更新者：Eli Lilly and Company

敗血症性ショックの成人患者への連続 96 時間注入として投与されるドロトレコギン アルファ (活性化) の無作為化、二重盲検、プラセボ対照、多施設、第 3 相試験

このプラセボ対照研究の目的は、ドロトレコギン アルファ (活性化) 治療が、敗血症性ショックの現在の標準治療を受けている患者のプラセボ治療と比較して、敗血症性ショック患者の死亡率を大幅に低下させるかどうかを判断することです。 この研究では、敗血症性ショックおよび付随する重度のプロテイン C 欠乏症患者の 28 日死亡率の減少におけるドロトレコギン アルファ (活性化) の有効性も評価します。

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

1696

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Alabama
      • Birmingham、Alabama、アメリカ、35294
        • 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.
    • California
      • Loma Linda、California、アメリカ、92350
        • 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.
      • Long Beach、California、アメリカ、90806
        • 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.
      • San Diego、California、アメリカ、92123
        • 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.
    • Colorado
      • Colorado Springs、Colorado、アメリカ、80920
        • 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.
      • Denver、Colorado、アメリカ、80204
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    • Idaho
      • Idaho Falls、Idaho、アメリカ、83404
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    • Illinois
      • Chicago、Illinois、アメリカ、60611
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    • Iowa
      • Iowa City、Iowa、アメリカ、52242
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    • Kansas
      • Topeka、Kansas、アメリカ、66604
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    • Kentucky
      • Hazard、Kentucky、アメリカ、41701
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    • Michigan
      • Lansing、Michigan、アメリカ、48912
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    • Missouri
      • Chesterfield、Missouri、アメリカ、63017
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      • St Louis、Missouri、アメリカ、63131
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    • Montana
      • Missoula、Montana、アメリカ、59802
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    • New York
      • Brooklyn、New York、アメリカ、11215
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      • Staten Island、New York、アメリカ、10305
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    • North Carolina
      • Greensboro、North Carolina、アメリカ、27403
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    • Oregon
      • Portland、Oregon、アメリカ、97239
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    • Pennsylvania
      • Philadelphia、Pennsylvania、アメリカ、19107
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      • Pittsburgh、Pennsylvania、アメリカ、15240
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    • Texas
      • San Antonio、Texas、アメリカ、78229
        • 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.
    • Virginia
      • Norfolk、Virginia、アメリカ、23507
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  • イギリス
      • London、イギリス、SW17 0QY
        • 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.
    • Avon
      • Bristol、Avon、イギリス、BS2 8HW
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    • Devon
      • Plymouth、Devon、イギリス、PL6 8DH
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    • Essex
      • Chelmsford、Essex、イギリス、CM2 5ET
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    • Hampshire
      • Portsmouth、Hampshire、イギリス、P06 3LY
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    • Hants
      • Southampton、Hants、イギリス、SO16 6YD
        • 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.
    • Scotland
      • Edinburgh、Scotland、イギリス、EH4 2XU
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      • Glasgow、Scotland、イギリス、G42 9TY
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    • Surrey
      • Guildford、Surrey、イギリス、GU2 7XX
        • 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.
    • West Midlands
      • Birmingham、West Midlands、イギリス、B15 2TH
        • 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.
    • West Sussex
      • Chichester、West Sussex、イギリス、PO19 6SE
        • 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.
  • イタリア
      • Catania、イタリア、95124
        • 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.
      • Firenze、イタリア、50143
        • 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.
      • Milano、イタリア、20132
        • 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.
      • Monza、イタリア、20052
        • 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.
      • Novara、イタリア、28100
        • 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.
      • Padova、イタリア、35127
        • 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.
      • Rome、イタリア、00168
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      • Torino、イタリア、10126
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      • Varese、イタリア、21100
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  • インド
      • Bangalore、インド、560 002
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      • New Delhi、インド、110 025
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      • Pune、インド、411004
        • 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.
  • オランダ
      • Arnhem、オランダ、6815 AD
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      • Ede、オランダ、6716 RP
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      • Nijmegen、オランダ、8525 GA
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  • オーストラリア
    • Australian Capital Territory
      • Garran、Australian Capital Territory、オーストラリア、2605
        • 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.
    • New South Wales
      • Newcastle、New South Wales、オーストラリア、2305
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      • St. Leonards、New South Wales、オーストラリア、2065
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    • Queensland
      • Herston、Queensland、オーストラリア、4029
        • 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.
    • South Australia
      • Adelaide、South Australia、オーストラリア、5000
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    • Victoria
      • Box Hill、Victoria、オーストラリア、3128
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      • Epping、Victoria、オーストラリア、3076
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      • Heidelberg、Victoria、オーストラリア、3084
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      • Melbourne、Victoria、オーストラリア、3004
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      • Parkville、Victoria、オーストラリア、3050
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  • カナダ
    • Alberta
      • Calgary、Alberta、カナダ、T2N 2T9
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    • British Columbia
      • Vancouver、British Columbia、カナダ、V5Z 1M9
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    • Manitoba
      • Winnipeg、Manitoba、カナダ、R3A 1R9
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    • Ontario
      • Thunder Bay、Ontario、カナダ、P7B 6V4
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      • Toronto、Ontario、カナダ、M4N 3M5
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    • Quebec
      • Montreal、Quebec、カナダ、H4J 1C5
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      • Sherbrook、Quebec、カナダ、J1H 5N4
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  • スイス
      • Lugano、スイス、CH-69100
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      • St Gallen、スイス、CH-9007
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      • Zurich、スイス、CH-8091
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  • スペイン
      • Alcala De Henares、スペイン、28805
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      • Barcelona、スペイン、08035
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      • Burgos、スペイン、9005
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      • Getafe、スペイン、28905
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      • Las Palmas、スペイン、35010
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      • Madrid、スペイン、28040
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      • Murcia、スペイン、30008
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      • Palma De Mallorca、スペイン、7010
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      • Sabadell、スペイン、8208
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      • Sevilla、スペイン、41007
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      • Tortosa、スペイン、43500
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      • Valladolid、スペイン、47012
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  • チェコ共和国
      • Brno、チェコ共和国、656 91
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      • Hradec Kralove、チェコ共和国、500 05
        • 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.
      • Olomouc、チェコ共和国、775 20
        • 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.
      • Plzen、チェコ共和国、304 60
        • 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.
      • Prague、チェコ共和国、128 08
        • 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.
      • Usti Nad Labem、チェコ共和国、40113
        • 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.
  • ドイツ
      • Aachen、ドイツ、52074
        • 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.
      • Augsburg、ドイツ、86156
        • 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.
      • Berlin、ドイツ、13125
        • 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.
      • Gottingen、ドイツ、37075
        • 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.
      • Hamburg、ドイツ、20246
        • 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.
      • Heidelberg、ドイツ、69120
        • 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.
      • Kiel、ドイツ、24105
        • 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.
      • Munich、ドイツ、81377
        • 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.
  • ニュージーランド
      • Auckland、ニュージーランド、1640
        • 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.
      • Christchurch、ニュージーランド、8011
        • 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.
      • Grafton、ニュージーランド、1023
        • 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.
      • Hamilton、ニュージーランド、3204
        • 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.
      • Wellington、ニュージーランド、6022
        • 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.
  • フィンランド
      • Helsinki、フィンランド、00029
        • 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.
      • Jyvaskyla、フィンランド、40620
        • 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.
      • Kuopio、フィンランド、70211
        • 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.
      • Lahti、フィンランド、15850
        • 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.
      • Seinajoki、フィンランド、60220
        • 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.
      • Tampere、フィンランド、33520
        • 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.
  • フランス
      • Angers、フランス、49933
        • 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.
      • Argenteuil、フランス、95107
        • 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.
      • Bobigny、フランス、93009
        • 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.
      • Bordeaux、フランス、33076
        • 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.
      • Dijon、フランス、21079
        • 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.
      • La Roche Sur Yon、フランス、85000
        • 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.
      • Le Kremlin Bicetre、フランス、94275
        • 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.
      • Limoges、フランス、87042
        • 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.
      • Lyon、フランス、69437
        • 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.
      • Montpellier、フランス、34295
        • 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.
      • Nantes、フランス、44093
        • 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.
      • Nice、フランス、06202
        • 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.
      • Nimes、フランス、30029
        • 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.
      • Paris、フランス、75010
        • 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.
      • Poissy、フランス、78300
        • 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.
      • Poitiers、フランス、86021
        • 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.
      • Pringy、フランス、74370
        • 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.
      • Rennes、フランス、35033
        • 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.
      • Saint Michel、フランス、16 470
        • 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.
      • Saint-Etienne、フランス、42055
        • 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.
      • Toulon、フランス、83056
        • 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.
      • Tours、フランス、37044
        • 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.
      • Vandoeuvre-Les-Nancy、フランス、54500
        • 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.
  • ブラジル
      • Belo Horizonte、ブラジル、30140-093
        • 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.
      • Joinville、ブラジル、89202-050
        • 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.
      • Londrina、ブラジル、86038
        • 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.
      • Porto Alegre、ブラジル、90610-970
        • 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.
      • Sao Jose Rio Preto、ブラジル、15090
        • 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.
      • São Paulo、ブラジル、05403-000
        • 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.
  • ベルギー
      • Antwerp、ベルギー、2020
        • 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.
      • Antwerpen、ベルギー、2060
        • 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.
      • Brussels、ベルギー、1200
        • 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.
      • Edegem、ベルギー、2650
        • 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.
      • Genk、ベルギー、3600
        • 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.
      • Leuven、ベルギー、3000
        • 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.
      • Liège、ベルギー、4000
        • 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.
      • Ottignies、ベルギー、1340
        • 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.
      • Roeselare、ベルギー、8800
        • 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.
      • Wilrijk、ベルギー、2610
        • 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.
      • Yvoir、ベルギー、5530
        • 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.
  • ポルトガル
      • Lisbon、ポルトガル、1449-005
        • 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.
      • Porto、ポルトガル、4202-451
        • 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.
  • メキシコ
      • Mexico City、メキシコ、07760
        • 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.
      • Tlalpan、メキシコ、14000
        • 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.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

包含基準:

  • 18歳以上である必要があります
  • 感染の証拠が必要
  • -全身性炎症反応症候群（SIRS）を持っている必要があります
  • -昇圧剤依存性の敗血症性ショックが必要です

除外基準:

  • -治験薬の開始前に24時間以上昇圧療法（任意の用量）を受けている
  • -治験薬注入の開始前に36時間以上敗血症による臓器機能障害がある
  • -単一の臓器機能不全と最近の手術がある（研究登録から30日以内）
  • -治験薬注入の直前の12時間以内に手術が行われたか、手術後に活発な出血の証拠があるか、または注入期間中に手術を計画または予想していた
  • 既存の矯正不可能な病状を考慮して、28日間生存することは期待されていません

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：プラセボ
薬：プラセボ
0.9% 塩化ナトリウム、静脈内、96 時間
実験的：ドロトレコギン アルファ (活性化)
薬：ドロトレコギン アルファ (活性化)
24 マイクログラム/キログラム/時間、静脈内、96 時間 (hr)
他の名前：
  • LY203638
  • シグリス

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
28 日間の全死因死亡率
時間枠：28日目
28 日目のエンドポイントで何らかの原因で死亡した参加者の割合として表されます。
28日目

二次結果の測定

結果測定
メジャーの説明
時間枠
重度のプロテイン C 欠乏症の参加者における 28 日間の全死因死亡率
時間枠：28日目
28 日目のエンドポイントで何らかの原因で死亡した参加者の割合として表されます。 重度のプロテイン C 欠乏症の参加者は、プロテイン C レベルが正常下限 (LLN) の半分以下 (40% 以下) であった人です。
28日目
平均心血管逐次臓器不全評価 (SOFA) スコア 1 日目から 28 日目まで
時間枠：1日目から28日目
スコアの範囲は 0 (正常) から 4 (臓器不全) で、スコアが増加するほど心血管機能障害が増加していることを示します。 生存していない参加者は、死亡した日とその後毎日、スコア 4 (最悪のスコア) を受け取ります。
1日目から28日目
平均呼吸器逐次臓器不全評価 (SOFA) スコア 1 日目から 28 日目まで
時間枠：1日目から28日目
スコアの範囲は 0 (正常) から 4 (臓器不全) で、スコアが高くなるほど呼吸機能障害が増加していることを示します。 生存していない参加者は、死亡した日とその後毎日、スコア 4 (最悪のスコア) を受け取ります。
1日目から28日目
1日目から28日目までの平均腎順次臓器不全評価（SOFA）スコア
時間枠：1日目から28日目
スコアの範囲は 0 (正常) から 4 (臓器不全) で、スコアが高くなるほど腎機能障害が進行していることを示します。 生存していない参加者は、死亡した日とその後毎日、スコア 4 (最悪のスコア) を受け取ります。
1日目から28日目
90日死亡率
時間枠：90日目
90 日目のエンドポイントで何らかの原因で死亡した参加者のパーセンテージとして表されます。
90日目
180日死亡率
時間枠：180日目
180 日目のエンドポイントで何らかの原因で死亡した参加者の割合として表されます。
180日目
平均生存時間
時間枠：180日目
180日目
EuroQoL Questionnaire-5 ディメンション (EQ-5D) ベースラインでの Visual Analog Scale (VAS) スコア、28 日目、90 日目、180 日目
時間枠：ベースラインと 28 日目、90 日目、180 日目
EQ-5D VAS は、参加者の全体的な健康状態に対する介護者の印象を評価します。 スコアの範囲は 0 (最悪の健康状態) から 100 (最高の健康状態) で、スコアが高いほど健康状態が良好であることを示します。
ベースラインと 28 日目、90 日目、180 日目
EuroQoL Questionnaire-5 ディメンション (EQ-5D) ベースラインでの合計スコア、28、90、および 180 日目
時間枠：ベースラインと 28 日目、90 日目、180 日目
EQ-5D は、参加者の全体的な健康状態を評価するために使用されます。 可動性、セルフケア、普段の活動、痛み・不快感、不安・抑うつの5項目で構成。 各項目には 3 つの重大度レベル (いいえ、一部、深刻な問題) があります。 EQ-5D から計算された合計スコア (米国 [US] インデックス スコア) は、0 (生活の質が最悪) から 1.00 (生活の質が最高) の範囲です。
ベースラインと 28 日目、90 日目、180 日目
QOL Short Form-12 (SF-12) ベースラインでのスコア、28、90、および 180 日目
時間枠：ベースラインと 28 日目、90 日目、180 日目
SF-12 は、参加者の身体的健康 (身体的要素) と精神的健康 (精神的要素) を測定するための手段として使用されました。 各コンポーネントのスコアは 0 ～ 100 の範囲で、0 = 最低の健康状態、100 = 最高の健康状態です。
ベースラインと 28 日目、90 日目、180 日目
ベースラインから 28 日目のエンドポイントまでの任意の時点で、有害事象のために中止された参加者の割合
時間枠：28日目までのベースライン
28日目までのベースライン

その他の成果指標

結果測定
メジャーの説明
時間枠
ベースラインから28日目までの任意の時点でシステムオルガンクラス内で重篤な出血イベントを起こした参加者の割合
時間枠：28日目までのベースライン
重篤な出血イベントを経験した参加者の割合は、MedDRA 14.0 に基づいて System Organ Class (SOC) 用語で報告されています。 出血が重篤な事象として認定されるためには、重篤な有害事象の標準的な定義を満たすか、中枢神経系の出血または 2 日間で 1 日あたり 3 単位以上の赤血球の投与につながる出血事象である必要があります。連日。
28日目までのベースライン

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Eli Lilly and Company

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2008年3月1日

一次修了 (実際)

2011年9月1日

研究の完了 (実際)

2012年2月1日

試験登録日

最初に提出

2008年1月24日

QC基準を満たした最初の提出物

2008年1月24日

最初の投稿 (見積もり)

2008年1月30日

学習記録の更新

投稿された最後の更新 (見積もり)

2012年9月18日

QC基準を満たした最後の更新が送信されました

2012年8月20日

最終確認日

2012年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 11940
  • F1K-MC-EVDP (その他の識別子：Eli Lilly and Company)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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条件

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