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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00604214
Registration number
NCT00604214
Ethics application status
Date submitted
24/01/2008
Date registered
30/01/2008
Date last updated
18/09/2012
Titles & IDs
Public title
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock
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Scientific 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
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Secondary ID [1]
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0
F1K-MC-EVDP
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Secondary ID [2]
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0
11940
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sepsis
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Condition category
Condition code
Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Drotrecogin alfa (activated)
Treatment: Drugs - Placebo
Experimental: Drotrecogin alfa (activated) -
Placebo Comparator: Placebo -
Treatment: Drugs: Drotrecogin alfa (activated)
24 microgram/kilogram/hour, intravenous, 96 hours (hr)
Treatment: Drugs: Placebo
0.9% sodium chloride, intravenous, 96 hours
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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28-Day All-Cause Mortality
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Assessment method [1]
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Expressed as percentage of participants who died from any cause at Day 28 endpoint.
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Timepoint [1]
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Day 28
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Secondary outcome [1]
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28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency
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Assessment method [1]
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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%).
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Timepoint [1]
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Day 28
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Secondary outcome [2]
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Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
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Assessment method [2]
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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.
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Timepoint [2]
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Day 1 through Day 28
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Secondary outcome [3]
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Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
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Assessment method [3]
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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.
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Timepoint [3]
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Day 1 through Day 28
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Secondary outcome [4]
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Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
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Assessment method [4]
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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.
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Timepoint [4]
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Day 1 through Day 28
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Secondary outcome [5]
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90-Day Mortality
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Assessment method [5]
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Expressed as percentage of participants who died from any cause at Day 90 endpoint.
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Timepoint [5]
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Day 90
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Secondary outcome [6]
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180-Day Mortality
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Assessment method [6]
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Expressed as percentage of participants who died from any cause at Day 180 endpoint.
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Timepoint [6]
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Day 180
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Secondary outcome [7]
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Median Survival Time
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Assessment method [7]
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Timepoint [7]
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Day 180
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Secondary outcome [8]
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EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline and Days 28 and 90 and 180
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Secondary outcome [9]
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EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180
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Assessment method [9]
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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).
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Timepoint [9]
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Baseline and Days 28 and 90 and 180
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Secondary outcome [10]
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Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline and Days 28 and 90 and 180
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Secondary outcome [11]
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Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint
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Assessment method [11]
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Timepoint [11]
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Baseline through Day 28
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2012
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Sample size
Target
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Accrual to date
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Final
1696
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
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Recruitment hospital [1]
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0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Garran
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Recruitment hospital [2]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Newcastle
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Recruitment hospital [3]
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0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - St. Leonards
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Recruitment hospital [4]
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0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Herston
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Recruitment hospital [5]
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Adelaide
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Recruitment hospital [6]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Box Hill
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Recruitment hospital [7]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Epping
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Recruitment hospital [8]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Heidelberg
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Recruitment hospital [9]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Melbourne
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Recruitment hospital [10]
0
0
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. - Parkville
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2305 - Newcastle
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Recruitment postcode(s) [3]
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2065 - St. Leonards
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Recruitment postcode(s) [4]
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4029 - Herston
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Recruitment postcode(s) [5]
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5000 - Adelaide
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Recruitment postcode(s) [6]
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3128 - Box Hill
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Recruitment postcode(s) [7]
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3076 - Epping
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Recruitment postcode(s) [8]
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3084 - Heidelberg
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Recruitment postcode(s) [9]
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3004 - Melbourne
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Recruitment postcode(s) [10]
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3050 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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Alabama
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California
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Colorado
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Idaho
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Illinois
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Kansas
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Kentucky
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Michigan
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Missouri
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Ontario
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Brno
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Hradec Kralove
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Olomouc
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Plzen
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Prague
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Helsinki
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Finland
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Lahti
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Finland
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Seinajoki
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Finland
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Tampere
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Angers
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Argenteuil
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Bobigny
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Bordeaux
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Dijon
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La Roche Sur Yon
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Le Kremlin Bicetre
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Limoges
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Lyon
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France
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Montpellier
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France
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Nantes
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France
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Nice
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Nimes
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Paris
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Poissy
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Poitiers
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Rennes
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Saint Michel
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Toulon
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Tours
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France
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Vandoeuvre-Les-Nancy
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Germany
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Aachen
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Germany
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Augsburg
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Germany
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Berlin
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Germany
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Gottingen
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Kiel
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Germany
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Munich
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India
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India
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India
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Pune
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Italy
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Catania
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Italy
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Firenze
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Italy
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Milano
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Italy
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Monza
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Novara
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Italy
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Padova
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Italy
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Rome
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Arnhem
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Ede
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Funding & Sponsors
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Commercial sector/Industry
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Eli Lilly and Company
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00604214
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Contacts
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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)
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Eli Lilly and Company
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00604214
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