GR270773 In The Treatment Of Suspected Or Confirmed Gram-Negative Severe Sepsis In Adults

July 14, 2017 updated by: GlaxoSmithKline

A Prospective, Randomized, Double-blind, Placebo Controlled, Dose Ranging, Multi-Center Study of the Safety and Efficacy of Three Days Continuous Intravenous Infusion of GR270773 in the Treatment of Suspected or Confirmed Gram-negative Severe Sepsis in Adults

The primary objective is to estimate the size of the GR270773 treatment effect on 28-day all-cause mortality for two doses of GR270773 versus placebo in adult subjects with suspected or confirmed Gram-negative severe sepsis. GR270773 will be administered as a three-day continuous intravenous infusion.

Study Overview

Status

Completed

Conditions

Sepsis

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1415

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1842
    - GSK Investigational Site
  - Buenos Aires, Argentina
    - GSK Investigational Site
  - Buenos Aires, Argentina, 1432
    - GSK Investigational Site
  - Ciudad de Buenos Aires, Argentina
    - GSK Investigational Site
  - Moron-Provincia de Buenos Aires, Argentina, 1709
    - GSK Investigational Site
- Buenos Aires
  - Villa Sarmiento-Haedo, Buenos Aires, Argentina, 1706
    - GSK Investigational Site
- Córdova
  - Córdoba, Córdova, Argentina, 5000
    - GSK Investigational Site
Australia
- New South Wales
  - St Leonards, New South Wales, Australia, 2065
    - GSK Investigational Site
- Victoria
  - Footscray, Victoria, Australia, 3011
    - GSK Investigational Site
  - Heidelberg, Victoria, Australia, 3084
    - GSK Investigational Site
  - Nedlands, Victoria, Australia, 6009
    - GSK Investigational Site
- Western Australia
  - Fremantle, Western Australia, Australia, 6959
    - GSK Investigational Site
Austria
- - Innsbruck, Austria, A-6020
    - GSK Investigational Site
  - Vienna, Austria, A-1090
    - GSK Investigational Site
  - Vienna, Austria, A-1100
    - GSK Investigational Site
  - Vienna, Austria, A-1220
    - GSK Investigational Site
Belgium
- - Aalst, Belgium, 9300
    - GSK Investigational Site
  - Brussel, Belgium, 1090
    - GSK Investigational Site
  - Bruxelles, Belgium, 1200
    - GSK Investigational Site
  - Bruxelles, Belgium, 1070
    - GSK Investigational Site
  - Genk, Belgium, 3600
    - GSK Investigational Site
  - Gent, Belgium, 9000
    - GSK Investigational Site
  - Leuven, Belgium, 3000
    - GSK Investigational Site
  - Ottignies, Belgium, 1340
    - GSK Investigational Site
  - Yvoir, Belgium, 5530
    - GSK Investigational Site
Brazil
- - São Paulo, Brazil, 05651-901
    - GSK Investigational Site
- Paraná
  - Curitiba, Paraná, Brazil, 80069-900
    - GSK Investigational Site
- São Paulo
  - Ribeirão Preto, São Paulo, Brazil, 14085-000
    - GSK Investigational Site
Canada
- Alberta
  - Calgary, Alberta, Canada, T2V 1P9
    - GSK Investigational Site
  - Calgary, Alberta, Canada, T1Y 6J4
    - GSK Investigational Site
  - Calgary, Alberta, Canada, T2N 2T9
    - GSK Investigational Site
  - Edmonton, Alberta, Canada, T6G 2B7
    - GSK Investigational Site
  - Edmonton, Alberta, Canada, T5H 3V9
    - GSK Investigational Site
- British Columbia
  - New Westminster, British Columbia, Canada, V3L 3W4
    - GSK Investigational Site
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - GSK Investigational Site
  - Vancouver, British Columbia, Canada, V5Z 1C6
    - GSK Investigational Site
  - Victoria, British Columbia, Canada, V8R 1J8
    - GSK Investigational Site
  - Victoria, British Columbia, Canada, V8Z 6R5
    - GSK Investigational Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - GSK Investigational Site
  - Winnipeg, Manitoba, Canada, R3J 3M7
    - GSK Investigational Site
- New Brunswick
  - Saint John, New Brunswick, Canada, E2M 3W5
    - GSK Investigational Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 3A7
    - GSK Investigational Site
- Ontario
  - Ottawa, Ontario, Canada, K1H 8L6
    - GSK Investigational Site
  - Ottawa, Ontario, Canada, K1Y 4E9
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M4N 3M5
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M5B 1W8
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M5G 2N2
    - GSK Investigational Site
  - Toronto, Ontario, Canada, M5T 2S8
    - GSK Investigational Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 5H6
    - GSK Investigational Site
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H4J 1C5
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H3A 1A1
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H1T 2M4
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H2X 3J4
    - GSK Investigational Site
  - Montreal, Quebec, Canada, H2W 1T8
    - GSK Investigational Site
  - Sainte-Foy, Quebec, Canada, G1V 4G2
    - GSK Investigational Site
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - GSK Investigational Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 0W8
    - GSK Investigational Site
Chile
- Región Metro De Santiago
  - Santiago, Región Metro De Santiago, Chile, 8380456
    - GSK Investigational Site
  - Santiago, Región Metro De Santiago, Chile
    - GSK Investigational Site
Czechia
- - Brno, Czechia, 662 50
    - GSK Investigational Site
  - Ostrava - Poruba, Czechia, 708 52
    - GSK Investigational Site
  - Plzen, Czechia, 304 60
    - GSK Investigational Site
  - Praha 10, Czechia, 100 34
    - GSK Investigational Site
  - Praha 5, Czechia, 150 06
    - GSK Investigational Site
Estonia
- - Tallinn, Estonia, 13419
    - GSK Investigational Site
  - Tallinn, Estonia, 11312
    - GSK Investigational Site
  - Tartu, Estonia, 51014
    - GSK Investigational Site
Finland
- - Helsinki, Finland, 00029
    - GSK Investigational Site
  - Joensuu, Finland, 80210
    - GSK Investigational Site
  - Jyvaskyla, Finland, 40620
    - GSK Investigational Site
  - Kuopio, Finland, 70210
    - GSK Investigational Site
  - Lappeenranta, Finland, 53130
    - GSK Investigational Site
  - Mikkeli, Finland, 50100
    - GSK Investigational Site
  - Oulu, Finland, 90029
    - GSK Investigational Site
  - Seinajoki, Finland, 60220
    - GSK Investigational Site
  - Tampere, Finland, 33520
    - GSK Investigational Site
France
- - Angers, France, 49000
    - GSK Investigational Site
  - Argenteuil, France, 95107
    - GSK Investigational Site
  - Bourg en Bresse, France, 01012
    - GSK Investigational Site
  - Caen, France, 14000
    - GSK Investigational Site
  - Créteil, France, 94010
    - GSK Investigational Site
  - Le Chesnay cedex, France, 78157
    - GSK Investigational Site
  - Lille cedex, France, 59037
    - GSK Investigational Site
  - Limoges cedex, France, 87042
    - GSK Investigational Site
  - Lyon cedex, France, 69433
    - GSK Investigational Site
  - Marseille cedex 20, France, 13915
    - GSK Investigational Site
  - Marseille cedex 9, France, 13274
    - GSK Investigational Site
  - Montauban, France, 82000
    - GSK Investigational Site
  - Montpellier cedex 5, France, 34295
    - GSK Investigational Site
  - Nîmes, France, 30000
    - GSK Investigational Site
  - Paris, France, 75018
    - GSK Investigational Site
  - Paris, France, 75012
    - GSK Investigational Site
  - Paris cedex 10, France, 75475
    - GSK Investigational Site
  - Paris cedex 14, France, 75674
    - GSK Investigational Site
  - Paris cedex 14, France, 75679
    - GSK Investigational Site
  - Saint Michel, France, 16470
    - GSK Investigational Site
Germany
- - Berlin, Germany, 10117
    - GSK Investigational Site
  - Berlin, Germany, 13353
    - GSK Investigational Site
  - Berlin, Germany, 14050
    - GSK Investigational Site
  - Berlin, Germany, 10967
    - GSK Investigational Site
  - Berlin, Germany, 10249
    - GSK Investigational Site
  - Berlin, Germany, 12351
    - GSK Investigational Site
  - Berlin, Germany, 13585
    - GSK Investigational Site
  - Berlin, Germany, 12683
    - GSK Investigational Site
  - Bremen, Germany, 28325
    - GSK Investigational Site
  - Hamburg, Germany, 21075
    - GSK Investigational Site
- Baden-Wuerttemberg
  - Heidelberg, Baden-Wuerttemberg, Germany, 69126
    - GSK Investigational Site
  - Mannheim, Baden-Wuerttemberg, Germany, 68167
    - GSK Investigational Site
- Bayern
  - Augsburg, Bayern, Germany, 86156
    - GSK Investigational Site
  - Erlangen, Bayern, Germany, 91054
    - GSK Investigational Site
  - Muenchen, Bayern, Germany, 80804
    - GSK Investigational Site
  - Muenchen, Bayern, Germany, 81545
    - GSK Investigational Site
  - Nuernberg, Bayern, Germany, 90340
    - GSK Investigational Site
- Hessen
  - Frankfurt, Hessen, Germany, 60590
    - GSK Investigational Site
  - Giessen, Hessen, Germany, 35392
    - GSK Investigational Site
  - Marburg, Hessen, Germany, 35043
    - GSK Investigational Site
- Mecklenburg-Vorpommern
  - Greifswald, Mecklenburg-Vorpommern, Germany, 17487
    - GSK Investigational Site
  - Neubrandenburg, Mecklenburg-Vorpommern, Germany, 17036
    - GSK Investigational Site
  - Rostock, Mecklenburg-Vorpommern, Germany, 18057
    - GSK Investigational Site
  - Schwerin, Mecklenburg-Vorpommern, Germany, 19055
    - GSK Investigational Site
  - Wismar, Mecklenburg-Vorpommern, Germany, 23966
    - GSK Investigational Site
- Niedersachsen
  - Goettingen, Niedersachsen, Germany, 37075
    - GSK Investigational Site
  - Hannover, Niedersachsen, Germany, 30625
    - GSK Investigational Site
  - Hannover, Niedersachsen, Germany, 30659
    - GSK Investigational Site
- Nordrhein-Westfalen
  - Bielefeld, Nordrhein-Westfalen, Germany, 33617
    - GSK Investigational Site
  - Bonn, Nordrhein-Westfalen, Germany, 53127
    - GSK Investigational Site
  - Bonn, Nordrhein-Westfalen, Germany, 53111
    - GSK Investigational Site
  - Koeln, Nordrhein-Westfalen, Germany, 51109
    - GSK Investigational Site
  - Wuppertal, Nordrhein-Westfalen, Germany, 42283
    - GSK Investigational Site
- Rheinland-Pfalz
  - Ludwigshafen, Rheinland-Pfalz, Germany, 67063
    - GSK Investigational Site
  - Mainz, Rheinland-Pfalz, Germany, 55131
    - GSK Investigational Site
- Saarland
  - Homburg, Saarland, Germany, 66421
    - GSK Investigational Site
- Sachsen
  - Dresden, Sachsen, Germany, 01307
    - GSK Investigational Site
  - Leipzig, Sachsen, Germany, 04103
    - GSK Investigational Site
- Sachsen-Anhalt
  - Halle, Sachsen-Anhalt, Germany, 06120
    - GSK Investigational Site
- Schleswig-Holstein
  - Kiel, Schleswig-Holstein, Germany, 24105
    - GSK Investigational Site
  - Luebeck, Schleswig-Holstein, Germany, 23538
    - GSK Investigational Site
- Thueringen
  - Bad Berka, Thueringen, Germany, 99437
    - GSK Investigational Site
  - Erfurt, Thueringen, Germany, 99089
    - GSK Investigational Site
  - Jena, Thueringen, Germany, 07747
    - GSK Investigational Site
Greece
- - Athens, Greece, 10676
    - GSK Investigational Site
  - Athens, Greece, 11527
    - GSK Investigational Site
  - Athens, Greece, 11526
    - GSK Investigational Site
  - Haidari, Greece, 124 61
    - GSK Investigational Site
  - Kifisia, Greece, 14561
    - GSK Investigational Site
  - Rio, Patras, Greece, 265 00
    - GSK Investigational Site
  - Thessaloniki, Greece, 564 29
    - GSK Investigational Site
  - Thessaloniki, Greece, 54636
    - GSK Investigational Site
  - Thessaloniki, Greece, 570 10
    - GSK Investigational Site
Hong Kong
- - Kowloon, Hong Kong
    - GSK Investigational Site
  - Pokfulam, Hong Kong
    - GSK Investigational Site
  - Shatin, Hong Kong
    - GSK Investigational Site
  - Tuen Mun, New Territories, Hong Kong
    - GSK Investigational Site
Hungary
- - Budapest, Hungary, 1124
    - GSK Investigational Site
India
- - Bangalore, India, 560034
    - GSK Investigational Site
  - Chennai, India, 600016
    - GSK Investigational Site
  - Mangalore, India, 575 001
    - GSK Investigational Site
  - Mumbai, India, 400012
    - GSK Investigational Site
  - Pune, India, 411 011
    - GSK Investigational Site
  - Pune, India, 411 001
    - GSK Investigational Site
Israel
- - Afula, Israel, 18101
    - GSK Investigational Site
  - Beer-Sheva, Israel
    - GSK Investigational Site
  - Haifa, Israel, 31048
    - GSK Investigational Site
  - Kfar Saba, Israel, 44281
    - GSK Investigational Site
  - Zrifin, Israel, 70300
    - GSK Investigational Site
Korea, Republic of
- - Seoul, Korea, Republic of, 138-736
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 152-703
    - GSK Investigational Site
  - Seoul, Korea, Republic of, 135-710
    - GSK Investigational Site
Latvia
- - Riga, Latvia, LV 1002
    - GSK Investigational Site
  - Riga, Latvia, LV1079
    - GSK Investigational Site
  - Riga, Latvia, LV 1001
    - GSK Investigational Site
Malaysia
- - Kuala Lumpur, Malaysia, 59100
    - GSK Investigational Site
  - Kubang Kerian, Malaysia, 16150
    - GSK Investigational Site
Netherlands
- - Amsterdam, Netherlands, 1081 HV
    - GSK Investigational Site
  - Apeldoorn, Netherlands, 7334 DZ
    - GSK Investigational Site
  - Den Bosch, Netherlands, 5211 RW
    - GSK Investigational Site
  - EDE, Netherlands, 6716 RP
    - GSK Investigational Site
  - Leeuwarden, Netherlands, 8934 AD
    - GSK Investigational Site
  - Rotterdam, Netherlands, 3015 GD
    - GSK Investigational Site
  - Utrecht, Netherlands, 3584 CX
    - GSK Investigational Site
New Zealand
- - Auckland, New Zealand, 1001
    - GSK Investigational Site
  - Auckland, New Zealand, 1701
    - GSK Investigational Site
  - Christchurch, New Zealand, 8001
    - GSK Investigational Site
  - Tauranga, New Zealand, 3001
    - GSK Investigational Site
Portugal
- - Almada, Portugal, 2800-950
    - GSK Investigational Site
  - Amadora, Portugal, 2720-276
    - GSK Investigational Site
  - Lisboa, Portugal, 1649-035
    - GSK Investigational Site
  - Lisboa, Portugal, 1769-001
    - GSK Investigational Site
  - Lisboa, Portugal, 1169-050
    - GSK Investigational Site
  - Lisboa, Portugal, 1849-017
    - GSK Investigational Site
Puerto Rico
- - San Juan, Puerto Rico, 00921
    - GSK Investigational Site
Romania
- - Bucharest, Romania, 022328
    - GSK Investigational Site
  - Bucharest, Romania, 050098
    - GSK Investigational Site
  - Bucharest, Romania
    - GSK Investigational Site
  - Bucharest, Romania, 14461
    - GSK Investigational Site
  - Iasi, Romania
    - GSK Investigational Site
Russian Federation
- - Barnaul, Russian Federation, 656 045
    - GSK Investigational Site
  - Ekaterinburg, Russian Federation, 620109
    - GSK Investigational Site
  - Krasnodar, Russian Federation, 350042
    - GSK Investigational Site
  - Moscow, Russian Federation, 115446
    - GSK Investigational Site
  - Moscow, Russian Federation, 125101
    - GSK Investigational Site
  - Moscow, Russian Federation, 121552
    - GSK Investigational Site
  - Moscow, Russian Federation, 117049
    - GSK Investigational Site
  - Moscow, Russian Federation, 111538
    - GSK Investigational Site
  - Moscow, Russian Federation, 105203
    - GSK Investigational Site
  - Perm, Russian Federation, 614107
    - GSK Investigational Site
  - Perm, Russian Federation, 614990
    - GSK Investigational Site
  - Smolensk, Russian Federation, 214018
    - GSK Investigational Site
  - St. Petersburgh, Russian Federation, 192242
    - GSK Investigational Site
  - Tomsk, Russian Federation, 634 050
    - GSK Investigational Site
Slovenia
- - Celje, Slovenia, 3000
    - GSK Investigational Site
  - Ljubljana, Slovenia, 1000
    - GSK Investigational Site
  - Maribor, Slovenia, 2000
    - GSK Investigational Site
  - Novo Mesto, Slovenia, 8000
    - GSK Investigational Site
  - Slovenj Gradec, Slovenia, 2380
    - GSK Investigational Site
  - Šempeter pri Novi Gorici, Slovenia
    - GSK Investigational Site
South Africa
- - Auckland Park, Johannesburg, South Africa, 2006
    - GSK Investigational Site
  - Bloemfontein, South Africa, 9300
    - GSK Investigational Site
  - Cape Town, South Africa, 7925
    - GSK Investigational Site
  - George, South Africa, 6529
    - GSK Investigational Site
  - PO Medunsa, South Africa, 0204
    - GSK Investigational Site
- Gauteng
  - Johannesburg, Gauteng, South Africa, 2193
    - GSK Investigational Site
Spain
- - Badalona, Spain, 08916
    - GSK Investigational Site
  - Barcelona, Spain, 08035
    - GSK Investigational Site
  - Getafe, Spain, 28905
    - GSK Investigational Site
  - La Coruña, Spain, 15006
    - GSK Investigational Site
  - Madrid, Spain, 28041
    - GSK Investigational Site
  - Madrid, Spain, 28046
    - GSK Investigational Site
  - Palma de Mallorca, Spain, 07014
    - GSK Investigational Site
  - Sevilla, Spain, 41013
    - GSK Investigational Site
  - Sevilla, Spain, 41014
    - GSK Investigational Site
  - Tarrasa, Spain
    - GSK Investigational Site
  - Terrassa, Spain, 08227
    - GSK Investigational Site
  - Valencia, Spain, 46009
    - GSK Investigational Site
Sweden
- - Göteborg, Sweden, SE-416 85
    - GSK Investigational Site
  - Lund, Sweden, SE-221 85
    - GSK Investigational Site
  - Stockholm, Sweden, SE-141 86
    - GSK Investigational Site
Taiwan
- - Kaohsiung, Taiwan, 813
    - GSK Investigational Site
  - Taichung, Taiwan, 404
    - GSK Investigational Site
  - Taipei, Taiwan, 100
    - GSK Investigational Site
  - Tau-Yuan County, Taiwan
    - GSK Investigational Site
Thailand
- - Bangkok, Thailand, 10330
    - GSK Investigational Site
  - Bangkok, Thailand, 10700
    - GSK Investigational Site
  - Chiangmai, Thailand, 50200
    - GSK Investigational Site
United Kingdom
- - Leeds, United Kingdom, LS9 7TF
    - GSK Investigational Site
  - Leeds, United Kingdom, LS1 3EX
    - GSK Investigational Site
  - Sheffield, United Kingdom, S10 2JF
    - GSK Investigational Site
- Aberdeenshire
  - Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
    - GSK Investigational Site
- Berkshire
  - Reading, Berkshire, United Kingdom, RG1 7AN
    - GSK Investigational Site
- Lanarkshire
  - Glasgow, Lanarkshire, United Kingdom, G51 4TF
    - GSK Investigational Site
  - Glasgow, Lanarkshire, United Kingdom, G11 6NT
    - GSK Investigational Site
  - Glasgow, Lanarkshire, United Kingdom, G42 9TY
    - GSK Investigational Site
- Lancashire
  - Wigan, Lancashire, United Kingdom, WN6 9EP
    - GSK Investigational Site
- Merseyside
  - Liverpool, Merseyside, United Kingdom, L7 8XP
    - GSK Investigational Site
- Oxfordshire
  - Oxford, Oxfordshire, United Kingdom, OX3 9DU
    - GSK Investigational Site
- Somerset
  - Bath, Somerset, United Kingdom, BA1 3NG
    - GSK Investigational Site
- West Lothian
  - Livingston, West Lothian, United Kingdom, EH54 6PP
    - GSK Investigational Site
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - GSK Investigational Site
- Arizona
  - Phoenix, Arizona, United States, 85006
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85724
    - GSK Investigational Site
  - Tucson, Arizona, United States, 85711
    - GSK Investigational Site
- Arkansas
  - Bentonville, Arkansas, United States, 71712
    - GSK Investigational Site
  - Little Rock, Arkansas, United States, 72205
    - GSK Investigational Site
- California
  - Fresno, California, United States, 93720
    - GSK Investigational Site
  - Fullerton, California, United States, 92835
    - GSK Investigational Site
  - Loma Linda, California, United States, 92534
    - GSK Investigational Site
  - Los Angeles, California, United States, 90089
    - GSK Investigational Site
  - Orange, California, United States, 92868
    - GSK Investigational Site
  - Sacramento, California, United States, 95816
    - GSK Investigational Site
  - Sacramento, California, United States, 95819
    - GSK Investigational Site
  - San Jose, California, United States, 95119
    - GSK Investigational Site
  - Stanford, California, United States, 94305
    - GSK Investigational Site
  - Torrance, California, United States, 90509
    - GSK Investigational Site
  - Walnut Creek, California, United States, 94598
    - GSK Investigational Site
- Colorado
  - Colorado Springs, Colorado, United States, 80919
    - GSK Investigational Site
  - Denver, Colorado, United States, 80204
    - GSK Investigational Site
  - Denver, Colorado, United States, 80218
    - GSK Investigational Site
  - Denver, Colorado, United States, 80210
    - GSK Investigational Site
  - Fort Collins, Colorado, United States, 80524
    - GSK Investigational Site
- Connecticut
  - Stamford, Connecticut, United States, 06902
    - GSK Investigational Site
  - Waterbury, Connecticut, United States, 06708
    - GSK Investigational Site
- Delaware
  - Newark, Delaware, United States, 19718
    - GSK Investigational Site
- District of Columbia
  - Washington, D.C., District of Columbia, United States, 20010
    - GSK Investigational Site
- Florida
  - Atlantis, Florida, United States, 33462
    - GSK Investigational Site
  - Bay Pines, Florida, United States, 33744
    - GSK Investigational Site
  - Fort Lauderdale, Florida, United States, 33316
    - GSK Investigational Site
  - Melbourne, Florida, United States, 32901
    - GSK Investigational Site
  - New Port Richey, Florida, United States, 34655
    - GSK Investigational Site
  - Ocala, Florida, United States, 34471
    - GSK Investigational Site
  - Orlando, Florida, United States, 32803
    - GSK Investigational Site
  - Sarasota, Florida, United States, 34239
    - GSK Investigational Site
  - Tampa, Florida, United States, 33601
    - GSK Investigational Site
- Georgia
  - Atlanta, Georgia, United States, 30342
    - GSK Investigational Site
  - Augusta, Georgia, United States, 30909
    - GSK Investigational Site
  - Decatur, Georgia, United States, 30033
    - GSK Investigational Site
  - Rome, Georgia, United States, 30165
    - GSK Investigational Site
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - GSK Investigational Site
  - Honolulu, Hawaii, United States, 96817
    - GSK Investigational Site
  - Honolulu, Hawaii, United States, 96816
    - GSK Investigational Site
- Illinois
  - Chicago, Illinois, United States, 60611
    - GSK Investigational Site
  - Chicago, Illinois, United States, 60612
    - GSK Investigational Site
  - Chicago, Illinois, United States, 60612-7230
    - GSK Investigational Site
  - Maywood, Illinois, United States, 60153
    - GSK Investigational Site
  - Naperville, Illinois, United States, 60540
    - GSK Investigational Site
  - North Chicago, Illinois, United States, 60064
    - GSK Investigational Site
  - Oak Park, Illinois, United States, 60302
    - GSK Investigational Site
  - Peoria, Illinois, United States, 62526
    - GSK Investigational Site
- Indiana
  - Indianapolis, Indiana, United States, 46280
    - GSK Investigational Site
  - New Albany, Indiana, United States, 47510
    - GSK Investigational Site
- Iowa
  - Des Moines, Iowa, United States, 50314
    - GSK Investigational Site
  - Iowa City, Iowa, United States, 52242
    - GSK Investigational Site
- Kansas
  - Kansas City, Kansas, United States, 66160
    - GSK Investigational Site
  - Wichita, Kansas, United States, 67214
    - GSK Investigational Site
- Kentucky
  - Lexington, Kentucky, United States, 40536-0293
    - GSK Investigational Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70806
    - GSK Investigational Site
  - New Orleans, Louisiana, United States, 70112
    - GSK Investigational Site
  - Shreveport, Louisiana, United States, 77103
    - GSK Investigational Site
  - Slidell, Louisiana, United States, 70458
    - GSK Investigational Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - GSK Investigational Site
  - Baltimore, Maryland, United States, 21237-3998
    - GSK Investigational Site
  - Baltimore, Maryland, United States, 21287-5554
    - GSK Investigational Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - GSK Investigational Site
  - Boston, Massachusetts, United States, 02115
    - GSK Investigational Site
  - Springfield, Massachusetts, United States, 01199
    - GSK Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - GSK Investigational Site
  - Detroit, Michigan, United States, 48202
    - GSK Investigational Site
  - East Lansing, Michigan, United States, 48824
    - GSK Investigational Site
  - Flint, Michigan, United States, 48503
    - GSK Investigational Site
  - Kalamazoo, Michigan, United States, 49048
    - GSK Investigational Site
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - GSK Investigational Site
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - GSK Investigational Site
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - GSK Investigational Site
- Montana
  - Butte, Montana, United States, 59701
    - GSK Investigational Site
- New Jersey
  - Camden, New Jersey, United States, 08103-1489
    - GSK Investigational Site
  - Piscataway, New Jersey, United States, 08854
    - GSK Investigational Site
  - Somers Point, New Jersey, United States, 08244
    - GSK Investigational Site
- New York
  - Albany, New York, United States, 12208
    - GSK Investigational Site
  - Buffalo, New York, United States, 14215
    - GSK Investigational Site
  - New York, New York, United States, 10065
    - GSK Investigational Site
  - New York, New York, United States, 10021
    - GSK Investigational Site
  - New York, New York, United States, 10029
    - GSK Investigational Site
  - Syracuse, New York, United States, 13210
    - GSK Investigational Site
  - The Bronx, New York, United States, 10461
    - GSK Investigational Site
  - The Bronx, New York, United States, 10467-2490
    - GSK Investigational Site
- North Carolina
  - Durham, North Carolina, United States, 27705
    - GSK Investigational Site
  - Greensboro, North Carolina, United States, 27410
    - GSK Investigational Site
  - Greenville, North Carolina, United States, 27858
    - GSK Investigational Site
  - Winston-Salem, North Carolina, United States, 27103
    - GSK Investigational Site
- Ohio
  - Akron, Ohio, United States, 44307
    - GSK Investigational Site
  - Columbus, Ohio, United States, 43215
    - GSK Investigational Site
  - Columbus, Ohio, United States, 43210
    - GSK Investigational Site
  - Toledo, Ohio, United States, 43614-5809
    - GSK Investigational Site
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - GSK Investigational Site
- Oregon
  - Bend, Oregon, United States, 97701
    - GSK Investigational Site
  - Corvallis, Oregon, United States, 97330
    - GSK Investigational Site
- Pennsylvania
  - Bethlehem, Pennsylvania, United States, 18018
    - GSK Investigational Site
  - Monroeville, Pennsylvania, United States, 15146
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19140
    - GSK Investigational Site
  - Philadelphia, Pennsylvania, United States, 19141
    - GSK Investigational Site
  - Pittsburgh, Pennsylvania, United States, 15261
    - GSK Investigational Site
- Rhode Island
  - Pawtucket, Rhode Island, United States, 02860
    - GSK Investigational Site
  - Providence, Rhode Island, United States, 02903
    - GSK Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - GSK Investigational Site
  - Columbia, South Carolina, United States, 29203
    - GSK Investigational Site
  - Greenville, South Carolina, United States, 29605
    - GSK Investigational Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - GSK Investigational Site
  - Knoxville, Tennessee, United States, 37920
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37212
    - GSK Investigational Site
  - Nashville, Tennessee, United States, 37232
    - GSK Investigational Site
- Texas
  - Dallas, Texas, United States, 75231
    - GSK Investigational Site
  - Dallas, Texas, United States, 75390-9113
    - GSK Investigational Site
  - Fort Worth, Texas, United States, 76104
    - GSK Investigational Site
  - Houston, Texas, United States, 77030
    - GSK Investigational Site
  - Lackland Air Force Base, Texas, United States, 78236-5300
    - GSK Investigational Site
  - Lubbock, Texas, United States, 79430-8183
    - GSK Investigational Site
- Utah
  - Salt Lake City, Utah, United States, 84132
    - GSK Investigational Site
- Vermont
  - Burlington, Vermont, United States, 05401
    - GSK Investigational Site
- Virginia
  - Lynchburg, Virginia, United States, 24501
    - GSK Investigational Site
  - Norfolk, Virginia, United States, 23507
    - GSK Investigational Site
  - Richmond, Virginia, United States, 23249
    - GSK Investigational Site
  - Salem, Virginia, United States, 24153
    - GSK Investigational Site
- Washington
  - Bellingham, Washington, United States, 98226
    - GSK Investigational Site
  - Everett, Washington, United States, 98201
    - GSK Investigational Site
  - Seattle, Washington, United States, 98101
    - GSK Investigational Site
  - Tacoma, Washington, United States, 98405
    - GSK Investigational Site
- West Virginia
  - Huntington, West Virginia, United States, 25701-1693
    - GSK Investigational Site
- Wisconsin
  - Marshfield, Wisconsin, United States, 54449
    - GSK Investigational Site
  - Milwaukee, Wisconsin, United States, 53226
    - GSK Investigational Site
  - Milwaukee, Wisconsin, United States, 53215
    - GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion criteria:

Receiving parenteral antibiotic therapy for a suspected or confirmed Gram-negative infection.
Have at least one new hypoperfusion abnormality or at least one new onset organ failure resulting from the current septic episode.
Must be available and able to receive the first dose of study medication no more than 12 hours after the confirmation of a new hypoperfusion abnormality or new onset organ failure and within 36 hours after the initiation of new parenteral antibacterial therapy for the suspected or confirmed Gram-negative infection believed to be responsible for this episode of sepsis.

Exclusion criteria:

Subject is unlikely to remain in hospital for a minimum of three days (72 hours) following enrollment.
Subject has neutropenia (e.g., subject recently receiving cytotoxic chemotherapy with absolute neutrophil count <500/mcL or expected to decline to <500/mcL in the next 3 days).
Subject has known active hemolytic disease, immune hemolytic anemias, hemoglobinopathies (sickle cell anemia and thalassemia major).
Subject has a known bone marrow disorder of inadequate red cell production (eg, aplastic anemia, myelodysplasia).
Subject is at increased risk of complications from GR270773-related hemolysis due to the inability to increase cardiac function sufficiently to meet the demands for oxygen delivery.
Subject has a baseline hemoglobin (measured after adequate volume resuscitation) <9.0 g/dL (5.59 mmol/L).
Subject is currently being treated with XIGRIS (Drotrecogin alfa (activated)) or its use is considered imminent (ie., a decision to treat with XIGRIS has been made).
Subject has a history of allergic reaction to eggs (or egg products), soybeans, INTRALIPID, or any component of GR270773.
Subject has been designated as 'not full support do not resuscitate' (DNR), or other equivalent status which prohibits the use of life supporting interventions (e.g., mechanical ventilation, dialysis/hemofiltration, or others) thereby limiting the treatment options available.

Note: Subjects with advanced directives prohibiting only chest compression (CPR) are eligible for the study.

Subject has preexisting severe liver disease such as cirrhosis, primary biliary cirrhosis or known preexisting Child-Pugh class B or C liver dysfunction.
Subject is moribund (a state in which death is perceived to be imminent) or has a life expectancy of less than 3 months due to an underlying disease.
Subject is currently receiving one of the following prohibited concomitant medications; parenteral nutrition supplements containing lipid emulsions (e.g., INTRALIPID), amphotericin, liposomal amphotericin, or amphotericin B lipid complex.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With 28-Day All Cause Mortality Time Frame: Day 1 (post-infusion) up to Day 28 Follow-up	Mortality was assessed by the number of participants who died between days 1 and 28. A summary of death details was given which included whether the participant died between days 1 and 28, whether the death was related sepsis, cause of death, the source of the information, and whether the cause of death was verified by a death record. Participants who had withdrawn from study and all study assessments and for whom survival at day 28 could not be confirmed was treated as deaths for the primary endpoint. The difference in all-cause 28-day mortality rates for each treatment group versus the placebo group in the ITT Population was calculated as placebo - treatment.	Day 1 (post-infusion) up to Day 28 Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With New Onset Organ Failure, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrolment Time Frame: Baseline (Day 1, pre-infusion) up to Day 28 Follow-up	The new onset organ failure was defined as first time each of the following criteria were met after start of study medication up to Day 28. Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. Analysis was done treating the death as a new onset organ failure (counted in both the numerator and denominator).	Baseline (Day 1, pre-infusion) up to Day 28 Follow-up
Number of Participants With New Onset Organ Failure of Respiratory Failure, Cardiovascular Failure, Renal Failure and Coagulopathy, Regardless of Cause, Occurring During the 28 Days Post Enrollment in an Organ Not in Failure at Enrollment Time Frame: Baseline (Day 1, pre-infusion) up to Day 28 Follow up	Respiratory failure: defined by requiring mechanical ventilation not less than 24 hours due to surgery. Renal failure: defined by requiring the initiation of hemodialysis or hemofiltration. Coagulopathy: defined by disseminated intravascular coagulation (DIC) requiring transfusion with platelets or fresh frozen plasma or anticoagulant therapy. Cardiovascular failure: defined by sustained hypotension requiring vasopressor support of dopamine >5 microgram per kilogram per minute (µg/kg/min), epinephrine, norepinephrine, phenylephrine or vasopressin at any dose if used to increase blood pressure for >=6 continuous h. For each organ failure type and the number of new onset organ failures per participants for each organ failure type, the denominator only included participants who did not have that type of organ failure at Baseline. At Baseline a participant could enter the study with a type of organ failure, that type of failure was not reported as a new onset organ failure.	Baseline (Day 1, pre-infusion) up to Day 28 Follow up
Assessment of Safety/Tolerability by Determining the Number of Participants With Any Adverse Events (AE), Serious Adverse Events (SAE) and Fatal SAE Time Frame: Day 1 (pre-infusion) up to Day 28 Follow-up	An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition or common toxicity criteria (CTC) grade 4 laboratory abnormalities of national cancer institute not associated with the underlying sepsis unless more severe than expected for the participants condition.	Day 1 (pre-infusion) up to Day 28 Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 15, 2007

Study Registration Dates

First Submitted

August 18, 2004

First Submitted That Met QC Criteria

August 20, 2004

First Posted (Estimate)

August 23, 2004

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

July 14, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

EMD20001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Sepsis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations