Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00604214
First received: January 24, 2008
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Sepsis
Drug: Drotrecogin alfa (activated)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 28-Day All-Cause Mortality [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Expressed as percentage of participants who died from any cause at Day 28 endpoint.


Secondary Outcome Measures:
  • 28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Expressed as percentage of participants who died from any cause at Day 28 endpoint. Participants with severe protein C deficiency are those who had a protein C level ≤ half the lower limit of normal (LLN) (≤40%).

  • Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 [ Time Frame: Day 1 through Day 28 ] [ Designated as safety issue: No ]
    Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.

  • Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 [ Time Frame: Day 1 through Day 28 ] [ Designated as safety issue: No ]
    Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.

  • Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 [ Time Frame: Day 1 through Day 28 ] [ Designated as safety issue: No ]
    Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.

  • 90-Day Mortality [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
    Expressed as percentage of participants who died from any cause at Day 90 endpoint.

  • 180-Day Mortality [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
    Expressed as percentage of participants who died from any cause at Day 180 endpoint.

  • Median Survival Time [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
  • EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180 [ Time Frame: Baseline and Days 28 and 90 and 180 ] [ Designated as safety issue: No ]
    EQ-5D VAS assesses caregiver's impression of participant's overall health state. Scores range from 0 (worst health state) to 100 (best health state), with higher scores indicating a better health state.

  • EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180 [ Time Frame: Baseline and Days 28 and 90 and 180 ] [ Designated as safety issue: No ]
    The EQ-5D is used to assess participant's overall health. Consists of 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 3 severity levels (no, some, severe problems). Calculated from EQ-5D, total scores (United States [US] Index Score) range from 0 (worst quality of life) to 1.00 (best quality of life).

  • Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180 [ Time Frame: Baseline and Days 28 and 90 and 180 ] [ Designated as safety issue: No ]
    SF-12 was used as an instrument to measure participants' physical wellbeing (physical component) and mental wellbeing (mental component). Scores for each component range from 0-100, with 0= lowest wellbeing, and 100=highest wellbeing.

  • Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint [ Time Frame: Baseline through Day 28 ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28 [ Time Frame: Baseline through Day 28 ] [ Designated as safety issue: Yes ]
    Percentage of participants who experienced serious bleeding events are reported by System Organ Class (SOC) term based on MedDRA 14.0. For a bleeding to qualify as a serious event, it would have to meet the standard definition of a serious adverse event or be a central nervous system bleeding or a bleeding event that lead to administration of ≥3 units packed red blood cells/day for 2 consecutive days.


Enrollment: 1696
Study Start Date: March 2008
Study Completion Date: February 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Drotrecogin alfa (activated) Drug: Drotrecogin alfa (activated)
24 microgram/kilogram/hour, intravenous, 96 hours (hr)
Other Names:
  • LY203638
  • Xigris
Placebo Comparator: Placebo Drug: Placebo
0.9% sodium chloride, intravenous, 96 hours

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604214

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Dijon, France, 21079
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La Roche Sur Yon, France, 85000
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Le Kremlin Bicetre, France, 94275
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Limoges, France, 87042
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Lyon, France, 69437
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Montpellier, France, 34295
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Nantes, France, 44093
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Nice, France, 06202
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Nimes, France, 30029
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Paris, France, 75010
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Poissy, France, 78300
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Poitiers, France, 86021
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Pringy, France, 74370
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Rennes, France, 35033
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Saint Michel, France, 16 470
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Saint-Etienne, France, 42055
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Toulon, France, 83056
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Tours, France, 37044
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Vandoeuvre-Les-Nancy, France, 54500
Germany
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Aachen, Germany, 52074
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Augsburg, Germany, 86156
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Berlin, Germany, 13125
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Gottingen, Germany, 37075
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Hamburg, Germany, 20246
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Heidelberg, Germany, 69120
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Kiel, Germany, 24105
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Munich, Germany, 81377
India
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Bangalore, India, 560 002
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New Delhi, India, 110 025
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Pune, India, 411004
Italy
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Catania, Italy, 95124
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Firenze, Italy, 50143
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Milano, Italy, 20132
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Monza, Italy, 20052
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Novara, Italy, 28100
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Padova, Italy, 35127
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Rome, Italy, 00168
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Torino, Italy, 10126
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Varese, Italy, 21100
Mexico
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Mexico City, Mexico, 07760
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Tlalpan, Mexico, 14000
Netherlands
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Arnhem, Netherlands, 6815 AD
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Ede, Netherlands, 6716 RP
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Nijmegen, Netherlands, 8525 GA
New Zealand
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Auckland, New Zealand, 1640
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Christchurch, New Zealand, 8011
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Grafton, New Zealand, 1023
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Hamilton, New Zealand, 3204
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Wellington, New Zealand, 6022
Portugal
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Lisbon, Portugal, 1449-005
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Porto, Portugal, 4202-451
Spain
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Alcala De Henares, Spain, 28805
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Barcelona, Spain, 08035
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Burgos, Spain, 9005
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Getafe, Spain, 28905
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Las Palmas, Spain, 35010
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Madrid, Spain, 28040
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Murcia, Spain, 30008
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Palma De Mallorca, Spain, 7010
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Sabadell, Spain, 8208
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Sevilla, Spain, 41007
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Tortosa, Spain, 43500
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Valladolid, Spain, 47012
Switzerland
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Lugano, Switzerland, CH-69100
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St Gallen, Switzerland, CH-9007
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Zurich, Switzerland, CH-8091
United Kingdom
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Bristol, Avon, United Kingdom, BS2 8HW
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Plymouth, Devon, United Kingdom, PL6 8DH
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Chelmsford, Essex, United Kingdom, CM2 5ET
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Portsmouth, Hampshire, United Kingdom, P06 3LY
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Southampton, Hants, United Kingdom, SO16 6YD
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Edinburgh, Scotland, United Kingdom, EH4 2XU
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Glasgow, Scotland, United Kingdom, G42 9TY
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Guildford, Surrey, United Kingdom, GU2 7XX
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Birmingham, West Midlands, United Kingdom, B15 2TH
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Chichester, West Sussex, United Kingdom, PO19 6SE
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London, United Kingdom, SW17 0QY
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00604214     History of Changes
Other Study ID Numbers: 11940, F1K-MC-EVDP
Study First Received: January 24, 2008
Results First Received: August 20, 2012
Last Updated: August 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Sepsis
Septic shock

Additional relevant MeSH terms:
Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Drotrecogin alfa activated
Protein C
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 18, 2014