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

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ClinicalTrials.gov Identifier: NCT00604214
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : September 18, 2012
Last Update Posted : September 18, 2012
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sepsis Drug: Drotrecogin alfa (activated) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1696 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 28-Day All-Cause Mortality [ Time Frame: Day 28 ]
    Expressed as percentage of participants who died from any cause at Day 28 endpoint.


Secondary Outcome Measures :
  1. 28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency [ Time Frame: Day 28 ]
    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%).

  2. Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 [ Time Frame: Day 1 through Day 28 ]
    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.

  3. Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 [ Time Frame: Day 1 through Day 28 ]
    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.

  4. Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28 [ Time Frame: Day 1 through Day 28 ]
    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.

  5. 90-Day Mortality [ Time Frame: Day 90 ]
    Expressed as percentage of participants who died from any cause at Day 90 endpoint.

  6. 180-Day Mortality [ Time Frame: Day 180 ]
    Expressed as percentage of participants who died from any cause at Day 180 endpoint.

  7. Median Survival Time [ Time Frame: Day 180 ]
  8. 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 ]
    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.

  9. 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 ]
    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).

  10. 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 ]
    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.

  11. Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint [ Time Frame: Baseline through Day 28 ]

Other Outcome Measures:
  1. Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28 [ Time Frame: Baseline through Day 28 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604214


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00604214    
Other Study ID Numbers: 11940
F1K-MC-EVDP ( Other Identifier: Eli Lilly and Company )
First Posted: January 30, 2008    Key Record Dates
Results First Posted: September 18, 2012
Last Update Posted: September 18, 2012
Last Verified: August 2012
Keywords provided by Eli Lilly and Company:
Sepsis
Septic shock
Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Shock
Drotrecogin alfa activated
Anti-Infective Agents