The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death
- Registration Number
- NCT00568737
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Adult Patients with Severe Sepsis
- Detailed Description
Compared with placebo, drotrecogin alfa (activated) reduces 28-day all-cause mortality in adult patients with severe sepsis at low risk of death (for example, with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score \<25 or single organ dysfunction).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2640
Inclusion Criteria
- Adult patients with recent onset of severe sepsis or presence of a suspected or proven infection, and at least one induced organ dysfunction.
Exclusion Criteria
- Are indicated for the treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
- Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
- Platelet count less than 30,000/mm3.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo 0.9% sodium chloride 1 Drotrecogin alfa (activated) 24 microgram/kg/hr for 96 hours (+ or - 1 hour)
- Primary Outcome Measures
Name Time Method Efficacy 20 months
- Secondary Outcome Measures
Name Time Method Safety 20 months
Trial Locations
- Locations (1)
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.
🇫🇷Gleize, France