Phase 3 N=1,696 Randomized Double-blind Treatment

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

Sepsis

Bottom Line

View on ClinicalTrials.gov: NCT00604214 ↗

Enrolled (actual)

1,696

Serious AEs

12.9%

Results posted

Sep 2012

Primary outcome: Primary: 28-Day All-Cause Mortality — 26.4; 24.2 percentage of participants — p=0.313

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Drotrecogin alfa (activated) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Sep 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY 28-Day All-Cause Mortality	26.4; 24.2	0.313
SECONDARY 28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency	28.7; 30.8	0.540
SECONDARY Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	1.92; 1.84	0.181
SECONDARY Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	2.31; 2.29	0.733
SECONDARY Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28	1.38; 1.28	0.122
SECONDARY 90-Day Mortality	34.1; 32.7	0.556
SECONDARY 180-Day Mortality	36.6; 35.9	0.758
SECONDARY Median Survival Time	NA; NA	—
SECONDARY EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180	54.21; 54.37; 54.78; 55.24; 64.41; 65.18	0.788
SECONDARY EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180	0.60; 0.60; 0.51; 0.53; 0.71; 0.71	0.697
SECONDARY Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180	39.14; 39.22; 31.14; 31.13; 38.09; 40.03	0.482
SECONDARY Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint	4.4; 3.0	0.154

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00604214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.