NCT00604214

Brief Summary

The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
1,696

participants targeted

Target at P75+ for phase_3 sepsis

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_3 sepsis

Geographic Reach
18 countries

150 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 18, 2012

Completed
Last Updated

September 18, 2012

Status Verified

August 1, 2012

Enrollment Period

3.5 years

First QC Date

January 24, 2008

Results QC Date

August 20, 2012

Last Update Submit

August 20, 2012

Conditions

Sepsis

Keywords

SepsisSeptic shock

Outcome Measures

Primary Outcomes (1)

  • 28-Day All-Cause Mortality

    Expressed as percentage of participants who died from any cause at Day 28 endpoint.

    Day 28

Secondary Outcomes (11)

  • 28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency

    Day 28

  • Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

    Day 1 through Day 28

  • Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

    Day 1 through Day 28

  • Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

    Day 1 through Day 28

  • 90-Day Mortality

    Day 90

  • +6 more secondary outcomes

Other Outcomes (1)

  • Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28

    Baseline through Day 28

Study Arms (2)

Drotrecogin alfa (activated)

EXPERIMENTAL
Drug: Drotrecogin alfa (activated)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Drotrecogin alfa (activated)DRUG

24 microgram/kilogram/hour, intravenous, 96 hours (hr)

Also known as: LY203638, Xigris
Drotrecogin alfa (activated)
PlaceboDRUG

0.9% sodium chloride, intravenous, 96 hours

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18 years or older
  • Must have evidence of infection
  • Must have systemic inflammatory response syndrome (SIRS)
  • Must have vasopressor-dependent septic shock

You may not qualify if:

  • Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the start of study drug
  • Have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of the study drug infusion
  • Have single organ dysfunction and recent surgery (within 30 days of study entry)
  • Have had surgery performed within the 12-hour period immediately preceding the study drug infusion, or are postoperative with evidence of active bleeding, or have planned or anticipated surgery during the infusion period
  • Are not expected to survive 28 days given their preexisting uncorrectable medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (150)

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Birmingham, Alabama, 35294, United States

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Loma Linda, California, 92350, United States

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Long Beach, California, 90806, United States

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San Diego, California, 92123, United States

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Colorado Springs, Colorado, 80920, United States

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Denver, Colorado, 80204, United States

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Idaho Falls, Idaho, 83404, United States

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Chicago, Illinois, 60611, United States

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Iowa City, Iowa, 52242, United States

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Topeka, Kansas, 66604, United States

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Hazard, Kentucky, 41701, United States

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Lansing, Michigan, 48912, United States

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Chesterfield, Missouri, 63017, United States

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St Louis, Missouri, 63131, United States

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Missoula, Montana, 59802, United States

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Brooklyn, New York, 11215, United States

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Staten Island, New York, 10305, United States

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Greensboro, North Carolina, 27403, United States

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Portland, Oregon, 97239, United States

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Philadelphia, Pennsylvania, 19107, United States

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Pittsburgh, Pennsylvania, 15240, United States

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San Antonio, Texas, 78229, United States

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Norfolk, Virginia, 23507, United States

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Garran, Australian Capital Territory, 2605, Australia

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Newcastle, New South Wales, 2305, Australia

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St Leonards, New South Wales, 2065, Australia

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Herston, Queensland, 4029, Australia

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Adelaide, South Australia, 5000, Australia

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Box Hill, Victoria, 3128, Australia

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Epping, Victoria, 3076, Australia

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Heidelberg, Victoria, 3084, Australia

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Melbourne, Victoria, 3004, Australia

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Parkville, Victoria, 3050, Australia

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Antwerp, 2020, Belgium

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Antwerp, 2060, Belgium

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Brussels, 1200, Belgium

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Edegem, 2650, Belgium

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Genk, 3600, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Ottignies, 1340, Belgium

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Roeselare, 8800, Belgium

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Wilrijk, 2610, Belgium

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Yvoir, 5530, Belgium

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Belo Horizonte, 30140-093, Brazil

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Joinville, 89202-050, Brazil

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Londrina, 86038, Brazil

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Porto Alegre, 90610-970, Brazil

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Sao Jose Rio Preto, 15090, Brazil

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São Paulo, 05403-000, Brazil

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Calgary, Alberta, T2N 2T9, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Winnipeg, Manitoba, R3A 1R9, Canada

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Thunder Bay, Ontario, P7B 6V4, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Montreal, Quebec, H4J 1C5, Canada

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Sherbrook, Quebec, J1H 5N4, Canada

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Brno, 656 91, Czechia

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Hradec Králové, 500 05, Czechia

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Olomouc, 775 20, Czechia

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Pilsen, 304 60, Czechia

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Prague, 128 08, Czechia

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Ústí nad Labem, 40113, Czechia

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Helsinki, 00029, Finland

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Jyväskylä, 40620, Finland

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Kuopio, 70211, Finland

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Lahti, 15850, Finland

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Seinäjoki, 60220, Finland

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Tampere, 33520, Finland

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Angers, 49933, France

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Argenteuil, 95107, France

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Bobigny, 93009, France

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Bordeaux, 33076, France

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Dijon, 21079, France

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La Roche-sur-Yon, 85000, France

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Le Kremlin-Bicêtre, 94275, France

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Limoges, 87042, France

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Lyon, 69437, France

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Montpellier, 34295, France

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Nantes, 44093, France

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Nice, 06202, France

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Nîmes, 30029, France

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Paris, 75010, France

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Poissy, 78300, France

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Poitiers, 86021, France

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Rennes, 35033, France

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Saint-Etienne, 42055, France

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Saint-Michel, 16 470, France

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Toulon, 83056, France

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Tours, 37044, France

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Vandœuvre-lès-Nancy, 54500, France

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Aachen, 52074, Germany

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Augsburg, 86156, Germany

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Berlin, 13125, Germany

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Göttingen, 37075, Germany

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Hamburg, 20246, Germany

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Heidelberg, 69120, Germany

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Kiel, 24105, Germany

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Munich, 81377, Germany

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Bangalore, 560 002, India

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New Delhi, 110 025, India

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Pune, 411004, India

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Catania, 95124, Italy

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Florence, 50143, Italy

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Milan, 20132, Italy

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Monza, 20052, Italy

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Novara, 28100, Italy

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Padua, 35127, Italy

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Rome, 00168, Italy

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Torino, 10126, Italy

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Varese, 21100, Italy

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Mexico City, 07760, Mexico

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Tlalpan, 14000, Mexico

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Arnhem, 6815 AD, Netherlands

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Ede, 6716 RP, Netherlands

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Nijmegen, 8525 GA, Netherlands

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Auckland, 1640, New Zealand

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Christchurch, 8011, New Zealand

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Grafton, 1023, New Zealand

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Hamilton, 3204, New Zealand

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Wellington, 6022, New Zealand

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Lisbon, 1449-005, Portugal

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Porto, 4202-451, Portugal

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Alcalá de Henares, 28805, Spain

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Barcelona, 08035, Spain

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Burgos, 9005, Spain

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Getafe, 28905, Spain

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Las Palmas, 35010, Spain

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Madrid, 28040, Spain

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Murcia, 30008, Spain

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Palma de Mallorca, 7010, Spain

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Sabadell, 8208, Spain

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Seville, 41007, Spain

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Tortosa, 43500, Spain

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Valladolid, 47012, Spain

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Lugano, CH-69100, Switzerland

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Sankt Gallen, CH-9007, Switzerland

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Zurich, CH-8091, Switzerland

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Plymouth, Devon, PL6 8DH, United Kingdom

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Chelmsford, Essex, CM2 5ET, United Kingdom

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Southampton, Hants, SO16 6YD, United Kingdom

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Edinburgh, Scotland, EH4 2XU, United Kingdom

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Glasgow, Scotland, G42 9TY, United Kingdom

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Guildford, Surrey, GU2 7XX, United Kingdom

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Birmingham, West Midlands, B15 2TH, United Kingdom

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Chichester, West Sussex, PO19 6SE, United Kingdom

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London, SW17 0QY, United Kingdom

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Related Publications (2)

  • Povoa P, Salluh JI, Martinez ML, Guillamat-Prats R, Gallup D, Al-Khalidi HR, Thompson BT, Ranieri VM, Artigas A. Clinical impact of stress dose steroids in patients with septic shock: insights from the PROWESS-Shock trial. Crit Care. 2015 Apr 28;19(1):193. doi: 10.1186/s13054-015-0921-x.

    PMID: 25928214DERIVED

  • Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Finfer S, Gardlund B, Marshall JC, Rhodes A, Artigas A, Payen D, Tenhunen J, Al-Khalidi HR, Thompson V, Janes J, Macias WL, Vangerow B, Williams MD; PROWESS-SHOCK Study Group. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012 May 31;366(22):2055-64. doi: 10.1056/NEJMoa1202290. Epub 2012 May 22.

    PMID: 22616830DERIVED

Related Links

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

drotrecogin alfa activated

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2008

First Posted

January 30, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2011

Study Completion

February 1, 2012

Last Updated

September 18, 2012

Results First Posted

September 18, 2012

Record last verified: 2012-08

Locations

NL(3)US(23)ES(12)IN(3)BR(6)CZ(6)GB(11)CA(7)AU(10)ME(2)FI(6)FR(23)CH(3)BE(11)DE(8)IT(9)NZ(5)PT(2)