CompletedNCT00604214Updated Sep 18, 2012Results posted

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

A Phase 3 interventional study of Drotrecogin alfa (activated) and Placebo in Sepsis, sponsored by Eli Lilly and Company. Completed at 150 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-18.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,696
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Sepsis

Browse trials for

Shock, Septic 862

Keywords

Sepsis
Septic shock

In context

Shock, Septic

862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.

This study's enrollment of 1,696 is above the median of 80 across 530 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 1,696 participants (actual)

Study arms

Experimental
Drotrecogin alfa (activated)
Drug: Drotrecogin alfa (activated)
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugDrotrecogin alfa (activated)
24 microgram/kilogram/hour, intravenous, 96 hours (hr)
Also known as: LY203638, Xigris
DrugPlacebo
0.9% sodium chloride, intravenous, 96 hours

What researchers measure

Primary outcomes

28-Day All-Cause Mortality
Expressed as percentage of participants who died from any cause at Day 28 endpoint.
Time frame: Day 28

Secondary outcomes

28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency
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%).
Time frame: Day 28
Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score 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.
Time frame: Day 1 through Day 28
Average Respiratory Sequential Organ Failure Assessment (SOFA) Score 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.
Time frame: Day 1 through Day 28
Average Renal Sequential Organ Failure Assessment (SOFA) Score 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.
Time frame: Day 1 through Day 28
90-Day Mortality
Expressed as percentage of participants who died from any cause at Day 90 endpoint.
Time frame: Day 90
180-Day Mortality
Expressed as percentage of participants who died from any cause at Day 180 endpoint.
Time frame: Day 180
Median Survival Time
Time frame: Day 180
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 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.
Time frame: Baseline and Days 28 and 90 and 180
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 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).
Time frame: Baseline and Days 28 and 90 and 180
Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 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.
Time frame: Baseline and Days 28 and 90 and 180
Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint
Time frame: Baseline through Day 28

Other outcomes

Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From 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.
Time frame: Baseline through Day 28

Results

Posted Sep 18, 2012

Participant flow

Baseline to Day 28

Participant flow — Baseline to Day 28
Milestone	Drotrecogin Alfa (Activated)	Placebo
Started	851	845
Received study drug	833	833
Completed	623	632
Not completed	228	213
Withdrew: Death	223	202
Withdrew: Lost to follow-up	2	4
Withdrew: Withdrawal by subject	3	7

Day 29 to Day 90

Participant flow — Day 29 to Day 90
Milestone	Drotrecogin Alfa (Activated)	Placebo
Started	623	632
Completed	555	553
Not completed	68	79
Withdrew: Death	64	67
Withdrew: Lost to follow-up	4	6
Withdrew: Withdrawal by subject	0	6

Day 91 to Day 180

Participant flow — Day 91 to Day 180
Milestone	Drotrecogin Alfa (Activated)	Placebo
Started	555	553
Completed	529	521
Not completed	26	32
Withdrew: Death	19	23
Withdrew: Lost to follow-up	6	8
Withdrew: Withdrawal by subject	1	1

Outcome measures

Primary28-Day All-Cause Mortality

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

Time frame:: Day 28
Reported as:: Number · percentage of participants

28-Day All-Cause Mortality
percentage of participants	Drotrecogin Alfa (Activated)	Placebo
28-Day All-Cause Mortality	26.4	24.2

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · Chi-squared · p = 0.313 (No adjustment for multiple comparisons.) · Risk ratio (rr): 1.088 · 95% CI 0.923 to 1.283

Secondary28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency

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%).

Time frame:: Day 28
Reported as:: Number · percentage of participants

28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency
percentage of participants	Drotrecogin Alfa (Activated)	Placebo
28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency	28.7	30.8

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · Chi-squared · p = 0.540 (No adjustments for multiple comparisons.) · Risk ratio (rr): 0.930 · 95% CI 0.737 to 1.173

SecondaryAverage Cardiovascular Sequential Organ Failure Assessment (SOFA) Score 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.

Time frame:: Day 1 through Day 28
Reported as:: Mean · units on a scale

Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
units on a scale	Drotrecogin Alfa (Activated)	Placebo
Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	1.92 ± 1.31	1.84 ± 1.31

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.181 (No adjustments for multiple comparisons.)

SecondaryAverage Respiratory Sequential Organ Failure Assessment (SOFA) Score 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.

Time frame:: Day 1 through Day 28
Reported as:: Mean · units on a scale

Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
units on a scale	Drotrecogin Alfa (Activated)	Placebo
Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	2.31 ± 1.05	2.29 ± 1.05

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.733 (No adjustments for multiple comparisons.)

SecondaryAverage Renal Sequential Organ Failure Assessment (SOFA) Score 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.

Time frame:: Day 1 through Day 28
Reported as:: Mean · units on a scale

Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
units on a scale	Drotrecogin Alfa (Activated)	Placebo
Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	1.38 ± 1.42	1.28 ± 1.40

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.122 (No adjustments for multiple comparisons.)

Secondary90-Day Mortality

Expressed as percentage of participants who died from any cause at Day 90 endpoint.

Time frame:: Day 90
Reported as:: Number · percentage of participants

90-Day Mortality
percentage of participants	Drotrecogin Alfa (Activated)	Placebo
90-Day Mortality	34.1	32.7

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · Chi-squared · p = 0.556 (No adjustments for multiple comparisons.) · Risk ratio (rr): 1.042 · 95% CI 0.909 to 1.193

Secondary180-Day Mortality

Expressed as percentage of participants who died from any cause at Day 180 endpoint.

Time frame:: Day 180
Reported as:: Number · percentage of participants

180-Day Mortality
percentage of participants	Drotrecogin Alfa (Activated)	Placebo
180-Day Mortality	36.6	35.9

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · Chi-squared · p = 0.758 (No adjustments for multiple comparisons.) · Risk ratio (rr): 1.020 · 95% CI 0.898 to 1.160

SecondaryMedian Survival Time

Time frame:: Day 180
Reported as:: Median · days

Median Survival Time
days	Drotrecogin Alfa (Activated)	Placebo
Median Survival Time	NA (NA to NA)	NA (NA to NA)

SecondaryEuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 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.

Time frame:: Baseline and Days 28 and 90 and 180
Reported as:: Mean · units on a scale

EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180
units on a scale	Drotrecogin Alfa (Activated)	Placebo
Baseline (n=685, 679)	54.21 ± 26.99	54.37 ± 27.95
Day 28 (n=500, 476)	54.78 ± 23.46	55.24 ± 22.89
Day 90 (n=474, 469)	64.41 ± 21.00	65.18 ± 20.15
Day 180 (n=456, 443)	68.94 ± 20.19	69.08 ± 20.50

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.788 (P-value is for Baseline, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.730 (P-value is for Day 28, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.662 (P-value is for Day 90, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.846 (P-value is for Day 180, unadjusted for multiple comparisons.)

SecondaryEuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 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).

Time frame:: Baseline and Days 28 and 90 and 180
Reported as:: Mean · units on a scale

EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180
units on a scale	Drotrecogin Alfa (Activated)	Placebo
Baseline (n=702, 705)	0.60 ± 0.35	0.60 ± 0.35
Day 28 (n=509, 486)	0.51 ± 0.33	0.53 ± 0.33
Day 90 (n=480, 473)	0.71 ± 0.27	0.71 ± 0.28
Day 180 (n=458, 448)	0.77 ± 0.23	0.76 ± 0.25

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.697 (P-value is for Baseline, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.306 (P-value is for Day 28, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.645 (P-value is for Day 90, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.690 (P-value is for Day 180, unadjusted for multiple comparisons.)

SecondaryQuality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 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.

Time frame:: Baseline and Days 28 and 90 and 180
Reported as:: Median · units on a scale

Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180
units on a scale	Drotrecogin Alfa (Activated)	Placebo
Physical Component at Baseline (n=683, 696)	39.14 ± 12.04	39.22 ± 12.10
Physical Component at Day 28 (n=484, 465)	31.14 ± 10.29	31.13 ± 9.84
Physical Component at Day 90 (n=474, 459)	38.09 ± 11.17	40.03 ± 11.23
Physical Component at Day 180 (n=450, 444)	42.26 ± 10.80	41.59 ± 11.28
Mental Component at Baseline (n=683, 696)	45.44 ± 13.07	46.03 ± 12.88
Mental Component at Day 28 (n=484, 465)	40.57 ± 13.12	41.45 ± 12.59
Mental Component at Day 90 (n=474, 459)	47.53 ± 12.08	48.52 ± 12.36
Mental Component at Day 180 (n=450, 444)	50.42 ± 11.50	50.55 ± 11.70

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.482 (P-value is for physical component at Baseline, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.584 (P-value is for physical component at Day 28, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.164 (P-value is for physical component at Day 90, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.666 (P-value is for physical component at Day 180, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.786 (P-value is for mental component at Baseline, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.160 (P-value is for mental component at Day 28, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.696 (P-value is for mental component at Day 90, unadjusted for multiple comparisons.)
Drotrecogin Alfa (Activated) vs Placebo · ANOVA · p = 0.966 (P-value is for mental component at Day 180, unadjusted for multiple comparisons.)

Other pre-specifiedPercentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From 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.

Time frame:: Baseline through Day 28
Reported as:: Number · percentage of participants

Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28
percentage of participants	Drotrecogin Alfa (Activated)	Placebo
with ≥1 event	2.4	2.8
Gastrointestinal Disorders	1.1	0.7
Injury, Poisoning And Procedural Complications	0	0.6
Nervous System Disorders	0.4	0.4
Renal And Urinary Disorders	0.1	0
Respiratory, Thoracic And Mediastinal Disorders	0.4	0.4
Vascular Disorders	0.5	1.0

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · Fisher Exact · p = 0.758 (P-value is for participants with ≥1 event. No adjustments for multiple comparisons.)

SecondaryPercentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint

Time frame:: Baseline through Day 28
Reported as:: Number · percentage of participants

Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint
percentage of participants	Drotrecogin Alfa (Activated)	Placebo
Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint	4.4	3.0

Statistical analysis

Drotrecogin Alfa (Activated) vs Placebo · Fisher Exact · p = 0.154 (Unadjusted for multiple comparisons.)

Adverse events

Collected over Day 0 to Day 28. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Drotrecogin Alfa (Activated)	—	119/833 (14.3%)	151/833 (18.1%)
Placebo	—	96/833 (11.5%)	119/833 (14.3%)

Most frequent serious events

Showing 10 of 143

Most frequent serious events
Event	Drotrecogin Alfa (Activated)	Placebo
Cardiac arrestCardiac disorders	13/833	8/833
Gastrointestinal haemorrhageGastrointestinal disorders	6/833	3/833
Respiratory failureRespiratory, thoracic and mediastinal disorders	6/833	3/833
PneumoniaInfections and infestations	5/833	3/833
Myocardial infarctionCardiac disorders	4/833	1/833
UrosepsisInfections and infestations	4/833	2/833
Ischaemic strokeNervous system disorders	4/833	4/833
Acute myocardial infarctionCardiac disorders	3/833	1/833
Ventricular fibrillationCardiac disorders	3/833	0/833
Intestinal ischaemiaGastrointestinal disorders	3/833	1/833

Most frequent other events

Showing 10 of 112

Most frequent other events
Event	Drotrecogin Alfa (Activated)	Placebo
ThrombocytopeniaBlood and lymphatic system disorders	12/833	9/833
Activated partial thromboplastin time prolongedInvestigations	11/833	2/833
HaematuriaRenal and urinary disorders	11/833	9/833
Deep vein thrombosisVascular disorders	10/833	5/833
Catheter site haemorrhageGeneral disorders	9/833	4/833
Atrial fibrillationCardiac disorders	8/833	5/833
Post procedural haemorrhageInjury, poisoning and procedural complications	8/833	2/833
Gastric haemorrhageGastrointestinal disorders	6/833	2/833
Gastrointestinal haemorrhageGastrointestinal disorders	3/833	6/833
MelaenaGastrointestinal disorders	3/833	6/833

Baseline characteristics

Age Continuous
Age Continuous(years)	Drotrecogin Alfa (Activated)	Placebo	Total
Mean	63.42 ± 15.42	62.70 ± 16.41	63.06 ± 15.92

Sex: Female, Male
Sex: Female, Male(Participants)	Drotrecogin Alfa (Activated)	Placebo	Total
Female	360	379	739
Male	491	466	957

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	Drotrecogin Alfa (Activated)	Placebo	Total
Aboriginal/Torres Strait Islander	2	6	8
African	30	27	57
Caucasian	740	721	1461
East Asian/Pacific	21	10	31
Hispanic	21	32	53
Native American	3	4	7
West Asian (Indian Subcontinent)	34	45	79

Region of Enrollment
Region of Enrollment(participants)	Drotrecogin Alfa (Activated)	Placebo	Total
Portugal	3	5	8
United States	78	82	160
Finland	45	42	87
Spain	87	84	171
Switzerland	8	10	18
United Kingdom	44	49	93
Italy	54	53	107
India	40	41	81
France	235	229	464
Czech Republic	30	24	54
Mexico	7	7	14
Canada	36	43	79
Brazil	18	18	36
Belgium	69	70	139
Australia	36	28	64
Netherlands	15	15	30
Germany	22	23	45
New Zealand	24	22	46

Primary Site of Infection
Primary Site of Infection(participants)	Drotrecogin Alfa (Activated)	Placebo	Total
Abdomen	263	246	509
Blood	40	25	65
Bone	2	2	4
Central Nervous System	11	9	20
Head	2	3	5
Heart	3	3	6
Lung	369	375	744
Other	11	17	28
Pleura	2	5	7
Reproductive Tract	2	2	4
Skin or Skin Structure	48	45	93
Urinary Tract	97	112	209
Unknown	1	1	2

Cardiovascular Sequential Organ Failure Assessment (SOFA) Score
Cardiovascular Sequential Organ Failure Assessment (SOFA) Score(units on a scale)	Drotrecogin Alfa (Activated)	Placebo	Total
Mean	3.91 ± 0.32	3.89 ± 0.35	3.90 ± 0.33

Respiratory Sequential Organ Failure Assessment (SOFA) Score
Respiratory Sequential Organ Failure Assessment (SOFA) Score(units on a scale)	Drotrecogin Alfa (Activated)	Placebo	Total
Mean	2.78 ± 1.07	2.74 ± 1.08	2.76 ± 1.08

Renal Sequential Organ Failure Assessment (SOFA) Score
Renal Sequential Organ Failure Assessment (SOFA) Score(units on a scale)	Drotrecogin Alfa (Activated)	Placebo	Total
Mean	1.67 ± 1.33	1.60 ± 1.34	1.63 ± 1.33

3 further baseline measures are reported on the registry.

Study locations

150 sites

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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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Antwerpen, 2060, Belgium
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Antwerp, 2020, 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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LiÃ¨ge, 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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SÃ£o 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, Czech Republic
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Hradec Kralove, 500 05, Czech Republic
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Olomouc, 775 20, Czech Republic
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Plzen, 304 60, Czech Republic
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Prague, 128 08, Czech Republic
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Usti Nad Labem, 40113, Czech Republic
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Helsinki, 00029, Finland
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Jyvaskyla, 40620, Finland
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Kuopio, 70211, Finland
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Lahti, 15850, Finland
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Seinajoki, 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 Bicetre, 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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Nimes, 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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Pringy, 74370, France
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Rennes, 35033, France
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Saint Michel, 16 470, France
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Saint-Etienne, 42055, France
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Toulon, 83056, France
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Tours, 37044, France
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Vandoeuvre-Les-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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Gottingen, 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

Showing the first 100 of 150 sites across 18 countries.

References and documents

Publications

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. PubMed 25928214 ↗
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. PubMed 22616830 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00604214
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Jan 30, 2008
Start date: Mar 2008
Primary completion: Sep 2011
Completion: Feb 2012
Results posted: Sep 18, 2012
Last update: Sep 18, 2012

Study contacts

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)

study director · Eli Lilly and Company

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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

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