AzTrials
AzTrials

SepsisPhase 2NCT00089986

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

A Phase 2 study testing Intravenous GR270773- Phospholipid Emulsion in people with Sepsis, run by GlaxoSmithKline at 390 sites in 34 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis
What is being tested?
Intravenous GR270773- Phospholipid Emulsion
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,415 participants
Where
390 sitesin 34 countries
Study dates
1 Sep 2004to 15 Apr 2007
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 13Show fewer
  • 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.

Trial locations and contacts

390 sites in 34 countries.

390 sites in 34 countries

United States132 sites

  • GSK Investigational Site

    Akron, Ohio, 44307

  • GSK Investigational Site

    Albany, New York, 12208

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Atlantis, Florida, 33462

  • GSK Investigational Site

    Augusta, Georgia, 30909

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • GSK Investigational Site

    Baltimore, Maryland, 21237-3998

  • GSK Investigational Site

    Baltimore, Maryland, 21287-5554

  • GSK Investigational Site

    Baton Rouge, Louisiana, 70806

  • GSK Investigational Site

    Bay Pines, Florida, 33744

  • GSK Investigational Site

    Bellingham, Washington, 98226

  • GSK Investigational Site

    Bend, Oregon, 97701

  • GSK Investigational Site

    Bentonville, Arkansas, 71712

  • GSK Investigational Site

    Bethlehem, Pennsylvania, 18018

  • GSK Investigational Site

    Birmingham, Alabama, 35294

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Boston, Massachusetts, 02115

  • GSK Investigational Site

    Buffalo, New York, 14215

  • GSK Investigational Site

    Burlington, Vermont, 05401

  • GSK Investigational Site

    Butte, Montana, 59701

  • GSK Investigational Site

    Camden, New Jersey, 08103-1489

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Chattanooga, Tennessee, 37403

  • GSK Investigational Site

    Chicago, Illinois, 60611

  • GSK Investigational Site

    Chicago, Illinois, 60612-7230

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Colorado Springs, Colorado, 80919

  • GSK Investigational Site

    Columbia, South Carolina, 29203

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Columbus, Ohio, 43215

  • GSK Investigational Site

    Corvallis, Oregon, 97330

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Dallas, Texas, 75390-9113

  • GSK Investigational Site

    Decatur, Georgia, 30033

  • GSK Investigational Site

    Denver, Colorado, 80204

  • GSK Investigational Site

    Denver, Colorado, 80210

  • GSK Investigational Site

    Denver, Colorado, 80218

  • GSK Investigational Site

    Des Moines, Iowa, 50314

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    Duluth, Minnesota, 55805

  • GSK Investigational Site

    Durham, North Carolina, 27705

  • GSK Investigational Site

    East Lansing, Michigan, 48824

  • GSK Investigational Site

    Everett, Washington, 98201

  • GSK Investigational Site

    Flint, Michigan, 48503

  • GSK Investigational Site

    Fort Collins, Colorado, 80524

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Fullerton, California, 92835

  • GSK Investigational Site

    Greensboro, North Carolina, 27410

  • GSK Investigational Site

    Greenville, North Carolina, 27858

  • GSK Investigational Site

    Greenville, South Carolina, 29605

  • GSK Investigational Site

    Honolulu, Hawaii, 96813

  • GSK Investigational Site

    Honolulu, Hawaii, 96816

  • GSK Investigational Site

    Honolulu, Hawaii, 96817

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Huntington, West Virginia, 25701-1693

  • GSK Investigational Site

    Indianapolis, Indiana, 46280

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Jackson, Mississippi, 39202

  • GSK Investigational Site

    Kalamazoo, Michigan, 49048

  • GSK Investigational Site

    Kansas City, Kansas, 66160

  • GSK Investigational Site

    Knoxville, Tennessee, 37920

  • GSK Investigational Site

    Lackland Air Force Base, Texas, 78236-5300

  • GSK Investigational Site

    Lexington, Kentucky, 40536-0293

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Loma Linda, California, 92534

  • GSK Investigational Site

    Los Angeles, California, 90089

  • GSK Investigational Site

    Lubbock, Texas, 79430-8183

  • GSK Investigational Site

    Lynchburg, Virginia, 24501

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    Maywood, Illinois, 60153

  • GSK Investigational Site

    Melbourne, Florida, 32901

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53215

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Monroeville, Pennsylvania, 15146

  • GSK Investigational Site

    Naperville, Illinois, 60540

  • GSK Investigational Site

    Nashville, Tennessee, 37212

  • GSK Investigational Site

    Nashville, Tennessee, 37232

  • GSK Investigational Site

    New Albany, Indiana, 47510

  • GSK Investigational Site

    New Orleans, Louisiana, 70112

  • GSK Investigational Site

    New Port Richey, Florida, 34655

  • GSK Investigational Site

    New York, New York, 10021

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    New York, New York, 10065

  • GSK Investigational Site

    Newark, Delaware, 19718

  • GSK Investigational Site

    Norfolk, Virginia, 23507

  • GSK Investigational Site

    North Chicago, Illinois, 60064

  • GSK Investigational Site

    Oak Park, Illinois, 60302

  • GSK Investigational Site

    Ocala, Florida, 34471

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73104

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Orlando, Florida, 32803

  • GSK Investigational Site

    Pawtucket, Rhode Island, 02860

  • GSK Investigational Site

    Peoria, Illinois, 62526

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19141

  • GSK Investigational Site

    Phoenix, Arizona, 85006

  • GSK Investigational Site

    Piscataway, New Jersey, 08854

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15261

  • GSK Investigational Site

    Providence, Rhode Island, 02903

  • GSK Investigational Site

    Richmond, Virginia, 23249

  • GSK Investigational Site

    Rome, Georgia, 30165

  • GSK Investigational Site

    Sacramento, California, 95816

  • GSK Investigational Site

    Sacramento, California, 95819

  • GSK Investigational Site

    Salem, Virginia, 24153

  • GSK Investigational Site

    Salt Lake City, Utah, 84132

  • GSK Investigational Site

    San Jose, California, 95119

  • GSK Investigational Site

    Sarasota, Florida, 34239

  • GSK Investigational Site

    Seattle, Washington, 98101

  • GSK Investigational Site

    Shreveport, Louisiana, 77103

  • GSK Investigational Site

    Slidell, Louisiana, 70458

  • GSK Investigational Site

    Somers Point, New Jersey, 08244

  • GSK Investigational Site

    Springfield, Massachusetts, 01199

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Stamford, Connecticut, 06902

  • GSK Investigational Site

    Stanford, California, 94305

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tampa, Florida, 33601

  • GSK Investigational Site

    The Bronx, New York, 10461

  • GSK Investigational Site

    The Bronx, New York, 10467-2490

  • GSK Investigational Site

    Toledo, Ohio, 43614-5809

  • GSK Investigational Site

    Torrance, California, 90509

  • GSK Investigational Site

    Tucson, Arizona, 85711

  • GSK Investigational Site

    Tucson, Arizona, 85724

  • GSK Investigational Site

    Walnut Creek, California, 94598

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20010

  • GSK Investigational Site

    Waterbury, Connecticut, 06708

  • GSK Investigational Site

    Wichita, Kansas, 67214

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany44 sites

  • GSK Investigational Site

    Augsburg, Bavaria, 86156

  • GSK Investigational Site

    Bad Berka, Thuringia, 99437

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 10249

  • GSK Investigational Site

    Berlin, 10967

  • GSK Investigational Site

    Berlin, 12351

  • GSK Investigational Site

    Berlin, 12683

  • GSK Investigational Site

    Berlin, 13353

  • GSK Investigational Site

    Berlin, 13585

  • GSK Investigational Site

    Berlin, 14050

  • GSK Investigational Site

    Bielefeld, North Rhine-Westphalia, 33617

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53111

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53127

  • GSK Investigational Site

    Bremen, 28325

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51109

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Erfurt, Thuringia, 99089

  • GSK Investigational Site

    Erlangen, Bavaria, 91054

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Giessen, Hesse, 35392

  • GSK Investigational Site

    Göttingen, Lower Saxony, 37075

  • GSK Investigational Site

    Greifswald, Mecklenburg-Vorpommern, 17487

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06120

  • GSK Investigational Site

    Hamburg, 21075

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Hanover, Lower Saxony, 30659

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69126

  • GSK Investigational Site

    Homburg, Saarland, 66421

  • GSK Investigational Site

    Jena, Thuringia, 07747

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24105

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23538

  • GSK Investigational Site

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Mannheim, Baden-Wurttemberg, 68167

  • GSK Investigational Site

    Marburg, Hesse, 35043

  • GSK Investigational Site

    Munich, Bavaria, 80804

  • GSK Investigational Site

    Munich, Bavaria, 81545

  • GSK Investigational Site

    Neubrandenburg, Mecklenburg-Vorpommern, 17036

  • GSK Investigational Site

    Nuremberg, Bavaria, 90340

  • GSK Investigational Site

    Rostock, Mecklenburg-Vorpommern, 18057

  • GSK Investigational Site

    Schwerin, Mecklenburg-Vorpommern, 19055

  • GSK Investigational Site

    Wismar, Mecklenburg-Vorpommern, 23966

  • GSK Investigational Site

    Wuppertal, North Rhine-Westphalia, 42283

Other trials in Germany

Canada30 sites

  • GSK Investigational Site

    Calgary, Alberta, T1Y 6J4

  • GSK Investigational Site

    Calgary, Alberta, T2N 2T9

  • GSK Investigational Site

    Calgary, Alberta, T2V 1P9

  • GSK Investigational Site

    Chicoutimi, Quebec, G7H 5H6

  • GSK Investigational Site

    Edmonton, Alberta, T5H 3V9

  • GSK Investigational Site

    Edmonton, Alberta, T6G 2B7

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • GSK Investigational Site

    Halifax, Nova Scotia, B3H 3A7

  • GSK Investigational Site

    Montreal, Quebec, H1T 2M4

  • GSK Investigational Site

    Montreal, Quebec, H2W 1T8

  • GSK Investigational Site

    Montreal, Quebec, H2X 3J4

  • GSK Investigational Site

    Montreal, Quebec, H3A 1A1

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    New Westminster, British Columbia, V3L 3W4

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Ottawa, Ontario, K1Y 4E9

  • GSK Investigational Site

    Saint John, New Brunswick, E2M 3W5

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1V 4G2

  • GSK Investigational Site

    Saskatoon, Saskatchewan, S7N 0W8

  • GSK Investigational Site

    Sherbrooke, Quebec, J1H 5N4

  • GSK Investigational Site

    Toronto, Ontario, M4N 3M5

  • GSK Investigational Site

    Toronto, Ontario, M5B 1W8

  • GSK Investigational Site

    Toronto, Ontario, M5G 2N2

  • GSK Investigational Site

    Toronto, Ontario, M5T 2S8

  • GSK Investigational Site

    Vancouver, British Columbia, V5Z 1C6

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 1Y6

  • GSK Investigational Site

    Victoria, British Columbia, V8R 1J8

  • GSK Investigational Site

    Victoria, British Columbia, V8Z 6R5

  • GSK Investigational Site

    Winnipeg, Manitoba, R2H 2A6

  • GSK Investigational Site

    Winnipeg, Manitoba, R3J 3M7

Other trials in Canada

France20 sites

  • GSK Investigational Site

    Angers, 49000

  • GSK Investigational Site

    Argenteuil, 95107

  • GSK Investigational Site

    Bourg-en-Bresse, 01012

  • GSK Investigational Site

    Caen, 14000

  • GSK Investigational Site

    Créteil, 94010

  • GSK Investigational Site

    Le Chesnay, 78157

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Limoges, 87042

  • GSK Investigational Site

    Lyon, 69433

  • GSK Investigational Site

    Marseille, 13274

  • GSK Investigational Site

    Marseille, 13915

  • GSK Investigational Site

    Montauban, 82000

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Nîmes, 30000

  • GSK Investigational Site

    Paris, 75012

  • GSK Investigational Site

    Paris, 75018

  • GSK Investigational Site

    Paris, 75475

  • GSK Investigational Site

    Paris, 75674

  • GSK Investigational Site

    Paris, 75679

  • GSK Investigational Site

    Saint-Michel, 16470

Other trials in France

Russia14 sites

  • GSK Investigational Site

    Barnaul, 656 045

  • GSK Investigational Site

    Krasnodar, 350042

  • GSK Investigational Site

    Moscow, 105203

  • GSK Investigational Site

    Moscow, 111538

  • GSK Investigational Site

    Moscow, 115446

  • GSK Investigational Site

    Moscow, 117049

  • GSK Investigational Site

    Moscow, 121552

  • GSK Investigational Site

    Moscow, 125101

  • GSK Investigational Site

    Perm, 614107

  • GSK Investigational Site

    Perm, 614990

  • GSK Investigational Site

    Saint Petersburgh, 192242

  • GSK Investigational Site

    Smolensk, 214018

  • GSK Investigational Site

    Tomsk, 634 050

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

United Kingdom13 sites

  • GSK Investigational Site

    Aberdeen, Aberdeenshire, AB25 2ZD

  • GSK Investigational Site

    Bath, Somerset, BA1 3NG

  • GSK Investigational Site

    Glasgow, Lanarkshire, G11 6NT

  • GSK Investigational Site

    Glasgow, Lanarkshire, G42 9TY

  • GSK Investigational Site

    Glasgow, Lanarkshire, G51 4TF

  • GSK Investigational Site

    Leeds, LS1 3EX

  • GSK Investigational Site

    Leeds, LS9 7TF

  • GSK Investigational Site

    Liverpool, Merseyside, L7 8XP

  • GSK Investigational Site

    Livingston, West Lothian, EH54 6PP

  • GSK Investigational Site

    Oxford, Oxfordshire, OX3 9DU

  • GSK Investigational Site

    Reading, Berkshire, RG1 7AN

  • GSK Investigational Site

    Sheffield, S10 2JF

  • GSK Investigational Site

    Wigan, Lancashire, WN6 9EP

Other trials in United Kingdom

Spain12 sites

  • GSK Investigational Site

    A Coruña, 15006

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Getafe, 28905

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28046

  • GSK Investigational Site

    Palma de Mallorca, 07014

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Seville, 41014

  • GSK Investigational Site

    Tarrasa

  • GSK Investigational Site

    Terrassa, 08227

  • GSK Investigational Site

    Valencia, 46009

Other trials in Spain

Belgium9 sites

  • GSK Investigational Site

    Aalst, 9300

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Brussels, 1090

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Genk, 3600

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Ottignies, 1340

  • GSK Investigational Site

    Yvoir, 5530

Other trials in Belgium

Finland9 sites

  • GSK Investigational Site

    Helsinki, 00029

  • GSK Investigational Site

    Joensuu, 80210

  • GSK Investigational Site

    Jyväskylä, 40620

  • GSK Investigational Site

    Kuopio, 70210

  • GSK Investigational Site

    Lappeenranta, 53130

  • GSK Investigational Site

    Mikkeli, 50100

  • GSK Investigational Site

    Oulu, 90029

  • GSK Investigational Site

    Seinäjoki, 60220

  • GSK Investigational Site

    Tampere, 33520

Other trials in Finland

Greece9 sites

  • GSK Investigational Site

    Athens, 10676

  • GSK Investigational Site

    Athens, 11526

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Haidari, 124 61

  • GSK Investigational Site

    Kifissia, 14561

  • GSK Investigational Site

    Rio, Patras, 265 00

  • GSK Investigational Site

    Thessaloniki, 54636

  • GSK Investigational Site

    Thessaloniki, 564 29

  • GSK Investigational Site

    Thessaloniki, 570 10

Other trials in Greece

Argentina7 sites

  • GSK Investigational Site

    Buenos Aires, 1432

  • GSK Investigational Site

    Buenos Aires, 1842

  • GSK Investigational Site

    Buenos Aires

  • GSK Investigational Site

    Ciudad de Buenos Aires

  • GSK Investigational Site

    Córdoba, Córdoba Province, 5000

  • GSK Investigational Site

    Moron-Provincia de Buenos Aires, 1709

  • GSK Investigational Site

    Villa Sarmiento-Haedo, Buenos Aires, 1706

Other trials in Argentina

Netherlands7 sites

  • GSK Investigational Site

    's-Hertogenbosch, 5211 RW

  • GSK Investigational Site

    Amsterdam, 1081 HV

  • GSK Investigational Site

    Apeldoorn, 7334 DZ

  • GSK Investigational Site

    Ede, 6716 RP

  • GSK Investigational Site

    Leeuwarden, 8934 AD

  • GSK Investigational Site

    Rotterdam, 3015 GD

  • GSK Investigational Site

    Utrecht, 3584 CX

Other trials in Netherlands

India6 sites

  • GSK Investigational Site

    Bangalore, 560034

  • GSK Investigational Site

    Chennai, 600016

  • GSK Investigational Site

    Mangalore, 575 001

  • GSK Investigational Site

    Mumbai, 400012

  • GSK Investigational Site

    Pune, 411 001

  • GSK Investigational Site

    Pune, 411 011

Other trials in India

Portugal6 sites

  • GSK Investigational Site

    Almada, 2800-950

  • GSK Investigational Site

    Amadora, 2720-276

  • GSK Investigational Site

    Lisbon, 1169-050

  • GSK Investigational Site

    Lisbon, 1649-035

  • GSK Investigational Site

    Lisbon, 1769-001

  • GSK Investigational Site

    Lisbon, 1849-017

Other trials in Portugal

Slovenia6 sites

  • GSK Investigational Site

    Celje, 3000

  • GSK Investigational Site

    Ljubljana, 1000

  • GSK Investigational Site

    Maribor, 2000

  • GSK Investigational Site

    Novo Mesto, 8000

  • GSK Investigational Site

    Šempeter Pri Novi Gorici

  • GSK Investigational Site

    Slovenj Gradec, 2380

Other trials in Slovenia

South Africa6 sites

  • GSK Investigational Site

    Auckland Park, Johannesburg, 2006

  • GSK Investigational Site

    Bloemfontein, 9300

  • GSK Investigational Site

    Cape Town, 7925

  • GSK Investigational Site

    George, 6529

  • GSK Investigational Site

    Johannesburg, Gauteng, 2193

  • GSK Investigational Site

    PO Medunsa, 0204

Other trials in South Africa

Australia5 sites

  • GSK Investigational Site

    Footscray, Victoria, 3011

  • GSK Investigational Site

    Fremantle, Western Australia, 6959

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Nedlands, Victoria, 6009

  • GSK Investigational Site

    St Leonards, New South Wales, 2065

Other trials in Australia

Czechia5 sites

  • GSK Investigational Site

    Brno, 662 50

  • GSK Investigational Site

    Ostrava - Poruba, 708 52

  • GSK Investigational Site

    Pilsen, 304 60

  • GSK Investigational Site

    Prague, 100 34

  • GSK Investigational Site

    Prague, 150 06

Other trials in Czechia

Israel5 sites

  • GSK Investigational Site

    Afula, 18101

  • GSK Investigational Site

    Beersheba

  • GSK Investigational Site

    Haifa, 31048

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Zrifin, 70300

Other trials in Israel

Romania5 sites

  • GSK Investigational Site

    Bucharest, 022328

  • GSK Investigational Site

    Bucharest, 050098

  • GSK Investigational Site

    Bucharest, 14461

  • GSK Investigational Site

    Bucharest

  • GSK Investigational Site

    Iași

Other trials in Romania

Austria4 sites

  • GSK Investigational Site

    Innsbruck, A-6020

  • GSK Investigational Site

    Vienna, A-1090

  • GSK Investigational Site

    Vienna, A-1100

  • GSK Investigational Site

    Vienna, A-1220

Other trials in Austria

Hong Kong4 sites

  • GSK Investigational Site

    Kowloon

  • GSK Investigational Site

    Pokfulam

  • GSK Investigational Site

    Shatin

  • GSK Investigational Site

    Tuen Mun, New Territories

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New Zealand4 sites

  • GSK Investigational Site

    Auckland, 1001

  • GSK Investigational Site

    Auckland, 1701

  • GSK Investigational Site

    Christchurch, 8001

  • GSK Investigational Site

    Tauranga, 3001

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Taiwan4 sites

  • GSK Investigational Site

    Kaohsiung City, 813

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Tau-Yuan County

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Brazil3 sites

  • GSK Investigational Site

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  • GSK Investigational Site

    Ribeirão Preto, São Paulo, 14085-000

  • GSK Investigational Site

    São Paulo, 05651-901

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Estonia3 sites

  • GSK Investigational Site

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  • GSK Investigational Site

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  • GSK Investigational Site

    Tartu, 51014

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Latvia3 sites

  • GSK Investigational Site

    Riga, LV 1001

  • GSK Investigational Site

    Riga, LV 1002

  • GSK Investigational Site

    Riga, LV1079

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South Korea3 sites

  • GSK Investigational Site

    Seoul, 135-710

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    Seoul, 138-736

  • GSK Investigational Site

    Seoul, 152-703

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Sweden3 sites

  • GSK Investigational Site

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  • GSK Investigational Site

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  • GSK Investigational Site

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Thailand3 sites

  • GSK Investigational Site

    Bangkok, 10330

  • GSK Investigational Site

    Bangkok, 10700

  • GSK Investigational Site

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Chile2 sites

  • GSK Investigational Site

    Santiago, Región Metro de Santiago, 8380456

  • GSK Investigational Site

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Malaysia2 sites

  • GSK Investigational Site

    Kuala Lumpur, 59100

  • GSK Investigational Site

    Kubang Kerian, 16150

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Hungary1 site

  • GSK Investigational Site

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Puerto Rico1 site

  • GSK Investigational Site

    San Juan, 00921

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About this study

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.

Conditions
Sepsis
Being tested
Intravenous GR270773- Phospholipid Emulsion, Placebo
Keywords
severe sepsis, septic shock, Gram-negative infection, phospholipid emulsion
Medical subject headings
Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravenous GR270773- Phospholipid EmulsionDrug

  • PlaceboOther

    Also called Matched placebo infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With 28-Day All Cause Mortality

    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.

    Measured: Day 1 (post-infusion) up to Day 28 Follow-up

Secondary outcomes (3)

  1. 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

    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).

    Measured: Baseline (Day 1, pre-infusion) up to Day 28 Follow-up

  2. 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

    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.

    Measured: Baseline (Day 1, pre-infusion) up to Day 28 Follow up

  3. Assessment of Safety/Tolerability by Determining the Number of Participants With Any Adverse Events (AE), Serious Adverse Events (SAE) and Fatal SAE

    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.

    Measured: Day 1 (pre-infusion) up to Day 28 Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2004 (estimated)
  2. Study start1 Sep 2004
  3. Primary completion1 Apr 2007
  4. Study completion15 Apr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
1,415 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00089986
Sponsor's protocol ID
EMD20001
Status last verified
Jul 2017
First submitted
18 Aug 2004
Last updated
21 Aug 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intravenous GR270773- Phospholipid Emulsion in people with Sepsis, run by GlaxoSmithKline at 390 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 390 sites in United States, Germany, Canada, France, Russia and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With 28-Day All Cause Mortality (time frame: Day 1 (post-infusion) up to Day 28 Follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00089986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.

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