Trial · NCT00604214

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

NCT00604214, Phase 3, Completed, Eli Lilly and Company; results first posted 2012-09-18

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock. Trials, record NCT00604214. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00604214

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock
NCT number: NCT00604214
Status: Completed
Phases: Phase 3
Enrollment: 1,696 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Sepsis
Interventions: Drotrecogin alfa (activated), Placebo
First posted: 2008-01-30
Last updated: 2012-09-18
Results first posted: 2012-09-18

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	28-Day All-Cause Mortality	Day 28	Expressed as percentage of participants who died from any cause at Day 28 endpoint.
Secondary	28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency	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%).
Secondary	Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	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.
Secondary	Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	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.
Secondary	Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	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.
Secondary	90-Day Mortality	Day 90	Expressed as percentage of participants who died from any cause at Day 90 endpoint.
Secondary	180-Day Mortality	Day 180	Expressed as percentage of participants who died from any cause at Day 180 endpoint.
Secondary	Median Survival Time	Day 180
Secondary	EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180	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.
Secondary	EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180	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).

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	28-Day All-Cause Mortality	Day 28	All randomized participants with known mortality status at Day 28.	percentage of participants	NUMBER
SECONDARY	28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency	Day 28	All randomized participants with severe protein C deficiency at Baseline with known mortality status at Day 28.	percentage of participants	NUMBER
SECONDARY	Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	Day 1 through Day 28	All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.	units on a scale	MEAN
SECONDARY	Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	Day 1 through Day 28	All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.	units on a scale	MEAN
SECONDARY	Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	Day 1 through Day 28	All randomized participants with any post-baseline data on Day 1 through Day 28. For those days when a participant is alive, but no data are available, last observation carried forward (LOFC) is used to impute the missing data. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.	units on a scale	MEAN
SECONDARY	90-Day Mortality	Day 90	All randomized participants with known mortality status at Day 90.	percentage of participants	NUMBER
SECONDARY	180-Day Mortality	Day 180	All randomized participants with known mortality status at Day 180.	percentage of participants	NUMBER
SECONDARY	Median Survival Time	Day 180	All randomized participants excluding those with unknown mortality status at Day 180.	days	MEDIAN
SECONDARY	EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180	Baseline and Days 28 and 90 and 180	All randomized participants with EQ-5D VAS data at the specified time points.	units on a scale	MEAN
SECONDARY	EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180	Baseline and Days 28 and 90 and 180	All randomized participants with EQ-5D total score data at the specified time points.	units on a scale	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group64

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
28-Day All-Cause Mortality	Drotrecogin Alfa (Activated)	26.4		percentage of participants
28-Day All-Cause Mortality	Placebo	24.2		percentage of participants
28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency	Drotrecogin Alfa (Activated)	28.7		percentage of participants
28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency	Placebo	30.8		percentage of participants
Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	Drotrecogin Alfa (Activated)	1.92	Standard Deviation 1.31	units on a scale
Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	Placebo	1.84	Standard Deviation 1.31	units on a scale
Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	Drotrecogin Alfa (Activated)	2.31	Standard Deviation 1.05	units on a scale
Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	Placebo	2.29	Standard Deviation 1.05	units on a scale
Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	Drotrecogin Alfa (Activated)	1.38	Standard Deviation 1.42	units on a scale
Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	Placebo	1.28	Standard Deviation 1.40	units on a scale

1 to 10 of 64Source ClinicalTrials.gov

See all 64 results by group

Participant flow20

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Baseline to Day 28	STARTED	Drotrecogin Alfa (Activated)	851
Baseline to Day 28	STARTED	Placebo	845
Baseline to Day 28	Received Study Drug	Drotrecogin Alfa (Activated)	833
Baseline to Day 28	Received Study Drug	Placebo	833
Baseline to Day 28	COMPLETED	Drotrecogin Alfa (Activated)	623
Baseline to Day 28	COMPLETED	Placebo	632
Baseline to Day 28	NOT COMPLETED	Drotrecogin Alfa (Activated)	228
Baseline to Day 28	NOT COMPLETED	Placebo	213
Day 29 to Day 90	STARTED	Drotrecogin Alfa (Activated)	623
Day 29 to Day 90	STARTED	Placebo	632

1 to 10 of 20Source ClinicalTrials.gov

See all 20 participant flow

Adverse events510

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Drotrecogin Alfa (Activated)	3	833	7
other	Anaemia	Blood and lymphatic system disorders	Placebo	1	833	3
other	Autoimmune thrombocytopenia	Blood and lymphatic system disorders	Drotrecogin Alfa (Activated)	1	833	1
other	Autoimmune thrombocytopenia	Blood and lymphatic system disorders	Placebo	0	833	0
other	Coagulopathy	Blood and lymphatic system disorders	Drotrecogin Alfa (Activated)	2	833	3
other	Coagulopathy	Blood and lymphatic system disorders	Placebo	0	833	0
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Drotrecogin Alfa (Activated)	2	833	3
other	Disseminated intravascular coagulation	Blood and lymphatic system disorders	Placebo	1	833	1
other	Haemorrhagic anaemia	Blood and lymphatic system disorders	Drotrecogin Alfa (Activated)	1	833	1
other	Haemorrhagic anaemia	Blood and lymphatic system disorders	Placebo	0	833	0

1 to 10 of 510Source ClinicalTrials.gov

See all 510 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Drotrecogin Alfa (Activated)
Total, all-cause mortality	Placebo
Total, other adverse events	Drotrecogin Alfa (Activated)	151	833
Total, other adverse events	Placebo	119	833
Total, serious adverse events	Drotrecogin Alfa (Activated)	119	833
Total, serious adverse events	Placebo	96	833

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
22616830	DERIVED	PubMed
25928214	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Drotrecogin Alfa (Activated) vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00604214

GET https://conductscience.org/api/trials/v1/NCT00604214/results?page=2

API reference For AI assistants