Sepsis Clinical Trial
Official title:
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.
| Status | Completed |
| Enrollment | 1415 |
| Est. completion date | April 2007 |
| Est. primary completion date | April 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | GSK Investigational Site | Buenos Aires | |
| Argentina | GSK Investigational Site | Buenos Aires | |
| Argentina | GSK Investigational Site | Buenos Aires | |
| Argentina | GSK Investigational Site | Ciudad de Buenos Aires | |
| Argentina | GSK Investigational Site | Córdoba | Córdova |
| Argentina | GSK Investigational Site | Moron-Provincia de Buenos Aires | |
| Argentina | GSK Investigational Site | Villa Sarmiento-Haedo | Buenos Aires |
| Australia | GSK Investigational Site | Footscray | Victoria |
| Australia | GSK Investigational Site | Fremantle | Western Australia |
| Australia | GSK Investigational Site | Heidelberg | Victoria |
| Australia | GSK Investigational Site | Nedlands | Victoria |
| Australia | GSK Investigational Site | St Leonards | New South Wales |
| Austria | GSK Investigational Site | Innsbruck | |
| Austria | GSK Investigational Site | Vienna | |
| Austria | GSK Investigational Site | Vienna | |
| Austria | GSK Investigational Site | Vienna | |
| Belgium | GSK Investigational Site | Aalst | |
| Belgium | GSK Investigational Site | Brussel | |
| Belgium | GSK Investigational Site | Bruxelles | |
| Belgium | GSK Investigational Site | Bruxelles | |
| Belgium | GSK Investigational Site | Genk | |
| Belgium | GSK Investigational Site | Gent | |
| Belgium | GSK Investigational Site | Leuven | |
| Belgium | GSK Investigational Site | Ottignies | |
| Belgium | GSK Investigational Site | Yvoir | |
| Brazil | GSK Investigational Site | Curitiba | Paraná |
| Brazil | GSK Investigational Site | Ribeirão Preto | São Paulo |
| Brazil | GSK Investigational Site | São Paulo | |
| Canada | GSK Investigational Site | Calgary | Alberta |
| Canada | GSK Investigational Site | Calgary | Alberta |
| Canada | GSK Investigational Site | Calgary | Alberta |
| Canada | GSK Investigational Site | Chicoutimi | Quebec |
| Canada | GSK Investigational Site | Edmonton | Alberta |
| Canada | GSK Investigational Site | Edmonton | Alberta |
| Canada | GSK Investigational Site | Greenfield Park | Quebec |
| Canada | GSK Investigational Site | Halifax | Nova Scotia |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | New Westminster | British Columbia |
| Canada | GSK Investigational Site | Ottawa | Ontario |
| Canada | GSK Investigational Site | Ottawa | Ontario |
| Canada | GSK Investigational Site | Saint John | New Brunswick |
| Canada | GSK Investigational Site | Sainte-Foy | Quebec |
| Canada | GSK Investigational Site | Saskatoon | Saskatchewan |
| Canada | GSK Investigational Site | Sherbrooke | Quebec |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Toronto | Ontario |
| Canada | GSK Investigational Site | Vancouver | British Columbia |
| Canada | GSK Investigational Site | Vancouver | British Columbia |
| Canada | GSK Investigational Site | Victoria | British Columbia |
| Canada | GSK Investigational Site | Victoria | British Columbia |
| Canada | GSK Investigational Site | Winnipeg | Manitoba |
| Canada | GSK Investigational Site | Winnipeg | Manitoba |
| Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
| Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
| Czech Republic | GSK Investigational Site | Brno | |
| Czech Republic | GSK Investigational Site | Ostrava - Poruba | |
| Czech Republic | GSK Investigational Site | Plzen | |
| Czech Republic | GSK Investigational Site | Praha 10 | |
| Czech Republic | GSK Investigational Site | Praha 5 | |
| Estonia | GSK Investigational Site | Tallinn | |
| Estonia | GSK Investigational Site | Tallinn | |
| Estonia | GSK Investigational Site | Tartu | |
| Finland | GSK Investigational Site | Helsinki | |
| Finland | GSK Investigational Site | Joensuu | |
| Finland | GSK Investigational Site | Jyvaskyla | |
| Finland | GSK Investigational Site | Kuopio | |
| Finland | GSK Investigational Site | Lappeenranta | |
| Finland | GSK Investigational Site | Mikkeli | |
| Finland | GSK Investigational Site | Oulu | |
| Finland | GSK Investigational Site | Seinajoki | |
| Finland | GSK Investigational Site | Tampere | |
| France | GSK Investigational Site | Angers | |
| France | GSK Investigational Site | Argenteuil | |
| France | GSK Investigational Site | Bourg en Bresse | |
| France | GSK Investigational Site | Caen | |
| France | GSK Investigational Site | Créteil | |
| France | GSK Investigational Site | Le Chesnay cedex | |
| France | GSK Investigational Site | Lille cedex | |
| France | GSK Investigational Site | Limoges cedex | |
| France | GSK Investigational Site | Lyon cedex | |
| France | GSK Investigational Site | Marseille cedex 20 | |
| France | GSK Investigational Site | Marseille cedex 9 | |
| France | GSK Investigational Site | Montauban | |
| France | GSK Investigational Site | Montpellier cedex 5 | |
| France | GSK Investigational Site | Nîmes | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris | |
| France | GSK Investigational Site | Paris cedex 10 | |
| France | GSK Investigational Site | Paris cedex 14 | |
| France | GSK Investigational Site | Paris cedex 14 | |
| France | GSK Investigational Site | Saint Michel | |
| Germany | GSK Investigational Site | Augsburg | Bayern |
| Germany | GSK Investigational Site | Bad Berka | Thueringen |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Berlin | |
| Germany | GSK Investigational Site | Bielefeld | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Bonn | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Bonn | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Bremen | |
| Germany | GSK Investigational Site | Dresden | Sachsen |
| Germany | GSK Investigational Site | Erfurt | Thueringen |
| Germany | GSK Investigational Site | Erlangen | Bayern |
| Germany | GSK Investigational Site | Frankfurt | Hessen |
| Germany | GSK Investigational Site | Giessen | Hessen |
| Germany | GSK Investigational Site | Goettingen | Niedersachsen |
| Germany | GSK Investigational Site | Greifswald | Mecklenburg-Vorpommern |
| Germany | GSK Investigational Site | Halle | Sachsen-Anhalt |
| Germany | GSK Investigational Site | Hamburg | |
| Germany | GSK Investigational Site | Hannover | Niedersachsen |
| Germany | GSK Investigational Site | Hannover | Niedersachsen |
| Germany | GSK Investigational Site | Heidelberg | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Homburg | Saarland |
| Germany | GSK Investigational Site | Jena | Thueringen |
| Germany | GSK Investigational Site | Kiel | Schleswig-Holstein |
| Germany | GSK Investigational Site | Koeln | Nordrhein-Westfalen |
| Germany | GSK Investigational Site | Leipzig | Sachsen |
| Germany | GSK Investigational Site | Ludwigshafen | Rheinland-Pfalz |
| Germany | GSK Investigational Site | Luebeck | Schleswig-Holstein |
| Germany | GSK Investigational Site | Mainz | Rheinland-Pfalz |
| Germany | GSK Investigational Site | Mannheim | Baden-Wuerttemberg |
| Germany | GSK Investigational Site | Marburg | Hessen |
| Germany | GSK Investigational Site | Muenchen | Bayern |
| Germany | GSK Investigational Site | Muenchen | Bayern |
| Germany | GSK Investigational Site | Neubrandenburg | Mecklenburg-Vorpommern |
| Germany | GSK Investigational Site | Nuernberg | Bayern |
| Germany | GSK Investigational Site | Rostock | Mecklenburg-Vorpommern |
| Germany | GSK Investigational Site | Schwerin | Mecklenburg-Vorpommern |
| Germany | GSK Investigational Site | Wismar | Mecklenburg-Vorpommern |
| Germany | GSK Investigational Site | Wuppertal | Nordrhein-Westfalen |
| Greece | GSK Investigational Site | Athens | |
| Greece | GSK Investigational Site | Athens | |
| Greece | GSK Investigational Site | Athens | |
| Greece | GSK Investigational Site | Haidari | |
| Greece | GSK Investigational Site | Kifisia | |
| Greece | GSK Investigational Site | Rio, Patras | |
| Greece | GSK Investigational Site | Thessaloniki | |
| Greece | GSK Investigational Site | Thessaloniki | |
| Greece | GSK Investigational Site | Thessaloniki | |
| Hong Kong | GSK Investigational Site | Kowloon | |
| Hong Kong | GSK Investigational Site | Pokfulam | |
| Hong Kong | GSK Investigational Site | Shatin | |
| Hong Kong | GSK Investigational Site | Tuen Mun, New Territories | |
| Hungary | GSK Investigational Site | Budapest | |
| India | GSK Investigational Site | Bangalore | |
| India | GSK Investigational Site | Chennai | |
| India | GSK Investigational Site | Mangalore | |
| India | GSK Investigational Site | Mumbai | |
| India | GSK Investigational Site | Pune | |
| India | GSK Investigational Site | Pune | |
| Israel | GSK Investigational Site | Afula | |
| Israel | GSK Investigational Site | Beer-Sheva | |
| Israel | GSK Investigational Site | Haifa | |
| Israel | GSK Investigational Site | Kfar Saba | |
| Israel | GSK Investigational Site | Zrifin | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Korea, Republic of | GSK Investigational Site | Seoul | |
| Latvia | GSK Investigational Site | Riga | |
| Latvia | GSK Investigational Site | Riga | |
| Latvia | GSK Investigational Site | Riga | |
| Malaysia | GSK Investigational Site | Kuala Lumpur | |
| Malaysia | GSK Investigational Site | Kubang Kerian | |
| Netherlands | GSK Investigational Site | Amsterdam | |
| Netherlands | GSK Investigational Site | Apeldoorn | |
| Netherlands | GSK Investigational Site | Den Bosch | |
| Netherlands | GSK Investigational Site | EDE | |
| Netherlands | GSK Investigational Site | Leeuwarden | |
| Netherlands | GSK Investigational Site | Rotterdam | |
| Netherlands | GSK Investigational Site | Utrecht | |
| New Zealand | GSK Investigational Site | Auckland | |
| New Zealand | GSK Investigational Site | Auckland | |
| New Zealand | GSK Investigational Site | Christchurch | |
| New Zealand | GSK Investigational Site | Tauranga | |
| Portugal | GSK Investigational Site | Almada | |
| Portugal | GSK Investigational Site | Amadora | |
| Portugal | GSK Investigational Site | Lisboa | |
| Portugal | GSK Investigational Site | Lisboa | |
| Portugal | GSK Investigational Site | Lisboa | |
| Portugal | GSK Investigational Site | Lisboa | |
| Puerto Rico | GSK Investigational Site | San Juan | |
| Romania | GSK Investigational Site | Bucharest | |
| Romania | GSK Investigational Site | Bucharest | |
| Romania | GSK Investigational Site | Bucharest | |
| Romania | GSK Investigational Site | Bucharest | |
| Romania | GSK Investigational Site | Iasi | |
| Russian Federation | GSK Investigational Site | Barnaul | |
| Russian Federation | GSK Investigational Site | Ekaterinburg | |
| Russian Federation | GSK Investigational Site | Krasnodar | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Perm | |
| Russian Federation | GSK Investigational Site | Perm | |
| Russian Federation | GSK Investigational Site | Smolensk | |
| Russian Federation | GSK Investigational Site | St. Petersburgh | |
| Russian Federation | GSK Investigational Site | Tomsk | |
| Slovenia | GSK Investigational Site | Šempeter pri Novi Gorici | |
| Slovenia | GSK Investigational Site | Celje | |
| Slovenia | GSK Investigational Site | Ljubljana | |
| Slovenia | GSK Investigational Site | Maribor | |
| Slovenia | GSK Investigational Site | Novo Mesto | |
| Slovenia | GSK Investigational Site | Slovenj Gradec | |
| South Africa | GSK Investigational Site | Auckland Park, Johannesburg | |
| South Africa | GSK Investigational Site | Bloemfontein | |
| South Africa | GSK Investigational Site | Cape Town | |
| South Africa | GSK Investigational Site | George | |
| South Africa | GSK Investigational Site | Johannesburg | Gauteng |
| South Africa | GSK Investigational Site | PO Medunsa | |
| Spain | GSK Investigational Site | Badalona | |
| Spain | GSK Investigational Site | Barcelona | |
| Spain | GSK Investigational Site | Getafe | |
| Spain | GSK Investigational Site | La Coruña | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Madrid | |
| Spain | GSK Investigational Site | Palma de Mallorca | |
| Spain | GSK Investigational Site | Sevilla | |
| Spain | GSK Investigational Site | Sevilla | |
| Spain | GSK Investigational Site | Tarrasa | |
| Spain | GSK Investigational Site | Terrassa | |
| Spain | GSK Investigational Site | Valencia | |
| Sweden | GSK Investigational Site | Göteborg | |
| Sweden | GSK Investigational Site | Lund | |
| Sweden | GSK Investigational Site | Stockholm | |
| Taiwan | GSK Investigational Site | Kaohsiung | |
| Taiwan | GSK Investigational Site | Taichung | |
| Taiwan | GSK Investigational Site | Taipei | |
| Taiwan | GSK Investigational Site | Tau-Yuan County | |
| Thailand | GSK Investigational Site | Bangkok | |
| Thailand | GSK Investigational Site | Bangkok | |
| Thailand | GSK Investigational Site | Chiangmai | |
| United Kingdom | GSK Investigational Site | Aberdeen | Aberdeenshire |
| United Kingdom | GSK Investigational Site | Bath | Somerset |
| United Kingdom | GSK Investigational Site | Glasgow | Lanarkshire |
| United Kingdom | GSK Investigational Site | Glasgow | Lanarkshire |
| United Kingdom | GSK Investigational Site | Glasgow | Lanarkshire |
| United Kingdom | GSK Investigational Site | Leeds | |
| United Kingdom | GSK Investigational Site | Leeds | |
| United Kingdom | GSK Investigational Site | Liverpool | Merseyside |
| United Kingdom | GSK Investigational Site | Livingston | West Lothian |
| United Kingdom | GSK Investigational Site | Oxford | Oxfordshire |
| United Kingdom | GSK Investigational Site | Reading | Berkshire |
| United Kingdom | GSK Investigational Site | Sheffield | |
| United Kingdom | GSK Investigational Site | Wigan | Lancashire |
| United States | GSK Investigational Site | Akron | Ohio |
| United States | GSK Investigational Site | Albany | New York |
| United States | GSK Investigational Site | Ann Arbor | Michigan |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlantis | Florida |
| United States | GSK Investigational Site | Augusta | Georgia |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Baton Rouge | Louisiana |
| United States | GSK Investigational Site | Bay Pines | Florida |
| United States | GSK Investigational Site | Bellingham | Washington |
| United States | GSK Investigational Site | Bend | Oregon |
| United States | GSK Investigational Site | Bentonville | Arkansas |
| United States | GSK Investigational Site | Bethlehem | Pennsylvania |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Bronx | New York |
| United States | GSK Investigational Site | Bronx | New York |
| United States | GSK Investigational Site | Buffalo | New York |
| United States | GSK Investigational Site | Burlington | Vermont |
| United States | GSK Investigational Site | Butte | Montana |
| United States | GSK Investigational Site | Camden | New Jersey |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Chattanooga | Tennessee |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Columbia | South Carolina |
| United States | GSK Investigational Site | Columbus | Ohio |
| United States | GSK Investigational Site | Columbus | Ohio |
| United States | GSK Investigational Site | Corvallis | Oregon |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Decatur | Georgia |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Des Moines | Iowa |
| United States | GSK Investigational Site | Detroit | Michigan |
| United States | GSK Investigational Site | Duluth | Minnesota |
| United States | GSK Investigational Site | Durham | North Carolina |
| United States | GSK Investigational Site | East Lansing | Michigan |
| United States | GSK Investigational Site | Everett | Washington |
| United States | GSK Investigational Site | Flint | Michigan |
| United States | GSK Investigational Site | Fort Collins | Colorado |
| United States | GSK Investigational Site | Fort Lauderdale | Florida |
| United States | GSK Investigational Site | Fort Worth | Texas |
| United States | GSK Investigational Site | Fresno | California |
| United States | GSK Investigational Site | Fullerton | California |
| United States | GSK Investigational Site | Greensboro | North Carolina |
| United States | GSK Investigational Site | Greenville | North Carolina |
| United States | GSK Investigational Site | Greenville | South Carolina |
| United States | GSK Investigational Site | Honolulu | Hawaii |
| United States | GSK Investigational Site | Honolulu | Hawaii |
| United States | GSK Investigational Site | Honolulu | Hawaii |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Huntington | West Virginia |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Iowa City | Iowa |
| United States | GSK Investigational Site | Jackson | Mississippi |
| United States | GSK Investigational Site | Kalamazoo | Michigan |
| United States | GSK Investigational Site | Kansas City | Kansas |
| United States | GSK Investigational Site | Knoxville | Tennessee |
| United States | GSK Investigational Site | Lackland Air Force Base | Texas |
| United States | GSK Investigational Site | Lexington | Kentucky |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Loma Linda | California |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Lubbock | Texas |
| United States | GSK Investigational Site | Lynchburg | Virginia |
| United States | GSK Investigational Site | Marshfield | Wisconsin |
| United States | GSK Investigational Site | Maywood | Illinois |
| United States | GSK Investigational Site | Melbourne | Florida |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Monroeville | Pennsylvania |
| United States | GSK Investigational Site | Naperville | Illinois |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | New Albany | Indiana |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | New Port Richey | Florida |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Newark | Delaware |
| United States | GSK Investigational Site | Norfolk | Virginia |
| United States | GSK Investigational Site | North Chicago | Illinois |
| United States | GSK Investigational Site | Oak Park | Illinois |
| United States | GSK Investigational Site | Ocala | Florida |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Orange | California |
| United States | GSK Investigational Site | Orlando | Florida |
| United States | GSK Investigational Site | Pawtucket | Rhode Island |
| United States | GSK Investigational Site | Peoria | Illinois |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Piscataway | New Jersey |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Providence | Rhode Island |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Rome | Georgia |
| United States | GSK Investigational Site | Sacramento | California |
| United States | GSK Investigational Site | Sacramento | California |
| United States | GSK Investigational Site | Salem | Virginia |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | San Jose | California |
| United States | GSK Investigational Site | Sarasota | Florida |
| United States | GSK Investigational Site | Seattle | Washington |
| United States | GSK Investigational Site | Shreveport | Louisiana |
| United States | GSK Investigational Site | Slidell | Louisiana |
| United States | GSK Investigational Site | Somers Point | New Jersey |
| United States | GSK Investigational Site | Springfield | Massachusetts |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | Stamford | Connecticut |
| United States | GSK Investigational Site | Stanford | California |
| United States | GSK Investigational Site | Syracuse | New York |
| United States | GSK Investigational Site | Tacoma | Washington |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Toledo | Ohio |
| United States | GSK Investigational Site | Torrance | California |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Walnut Creek | California |
| United States | GSK Investigational Site | Washington | District of Columbia |
| United States | GSK Investigational Site | Waterbury | Connecticut |
| United States | GSK Investigational Site | Wichita | Kansas |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Korea, Republic of, Latvia, Malaysia, Netherlands, New Zealand, Portugal, Puerto Rico, Romania, Russian Federation, Slovenia, South Africa, Spain, Sweden, Taiwan, Thailand, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 28-day all-cause mortality | 28 Days | ||
| Secondary | New onset organ failure in an organ not in failure at enrollment.Assess safety/tolerability by determining the incidence of adverse events in the GR270773 treatment groups versus placebo | 28 Days |
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