Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock
NCT ID: NCT00604214
Last Updated: 2012-09-18
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1696 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-03-31
Study Completion Date
2012-02-29
Brief Summary
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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.
Detailed Description
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Conditions
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Sepsis
Keywords
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Sepsis
Septic shock
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Drotrecogin alfa (activated)
Group Type
EXPERIMENTAL
Drotrecogin alfa (activated)
Intervention Type
DRUG
24 microgram/kilogram/hour, intravenous, 96 hours (hr)
Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
0.9% sodium chloride, intravenous, 96 hours
Interventions
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Drotrecogin alfa (activated)
24 microgram/kilogram/hour, intravenous, 96 hours (hr)
Intervention Type
DRUG
Placebo
0.9% sodium chloride, intravenous, 96 hours
Intervention Type
DRUG
Other Intervention Names
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LY203638
Xigris
Eligibility Criteria
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Inclusion Criteria
* Must be 18 years or older
* Must have evidence of infection
* Must have systemic inflammatory response syndrome (SIRS)
* Must have vasopressor-dependent septic shock
* Must have evidence of infection
* Must have systemic inflammatory response syndrome (SIRS)
* Must have vasopressor-dependent septic shock
Exclusion Criteria
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
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Poitiers, , France
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Pringy, , France
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Rennes, , France
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Saint-Etienne, , France
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Saint-Michel, , France
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Toulon, , France
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Tours, , France
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Vandœuvre-lès-Nancy, , France
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Aachen, , Germany
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Augsburg, , Germany
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Berlin, , Germany
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Göttingen, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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Kiel, , Germany
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Munich, , Germany
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Bangalore, , India
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New Delhi, , India
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Pune, , India
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Catania, , Italy
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Florence, , Italy
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Milan, , Italy
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Monza, , Italy
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Novara, , Italy
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Padua, , Italy
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Rome, , Italy
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Torino, , Italy
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Varese, , Italy
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Mexico City, , Mexico
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Tlalpan, , Mexico
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Arnhem, , Netherlands
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Ede, , Netherlands
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Nijmegen, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Grafton, , New Zealand
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Hamilton, , New Zealand
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Wellington, , New Zealand
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Lisbon, , Portugal
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Porto, , Portugal
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Alcalá de Henares, , Spain
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Barcelona, , Spain
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Burgos, , Spain
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Getafe, , Spain
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Las Palmas, , Spain
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Madrid, , Spain
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Murcia, , Spain
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Palma de Mallorca, , Spain
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Sabadell, , Spain
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Seville, , Spain
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Tortosa, , Spain
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Valladolid, , Spain
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Lugano, , Switzerland
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Sankt Gallen, , Switzerland
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Zurich, , Switzerland
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Bristol, Avon, United Kingdom
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Plymouth, Devon, United Kingdom
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Chelmsford, Essex, United Kingdom
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Portsmouth, Hampshire, United Kingdom
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Southampton, Hants, United Kingdom
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Edinburgh, Scotland, United Kingdom
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Glasgow, Scotland, United Kingdom
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Guildford, Surrey, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Chichester, West Sussex, United Kingdom
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London, , United Kingdom
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Countries
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Argentina
United States
Australia
Belgium
Brazil
Canada
Czechia
Finland
France
Germany
India
Italy
Mexico
Netherlands
New Zealand
Portugal
Spain
Switzerland
United Kingdom
References
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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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
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F1K-MC-EVDP
Identifier Type: OTHER
Identifier Source: secondary_id
11940
Identifier Type: -
Identifier Source: org_study_id