Severe Sepsis
Conditions
Brief summary
This trial is to obtain safety data in adult patients with severe sepsis and two sepsis-induced organ infections who receive an infusion of drotrecogin alfa (activated).
Detailed description
To collect safety data while providing drotrecogin alfa (activated) for the treatment of patients with severe sepsis with multiple organ dysfunctions. Patient access to drotrecogin alfa (activated) will be provided under this protocol prior to and during its review by the Authorities of Belgium and Luxemburg for commercial release.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients greater than or equal 18 years of age may be included in this study only if they meet all of the following criteria: 1. Must be 18 years. 2. Suspected or proven infection 3. Have or have had two or more sepsis-induced organ failures sepsis
Exclusion criteria
* Patients will be excluded from entry in this study for any of the following reasons: 1. Documented first organ dysfunction greater than 48-hours prior to start of study drug. 2. Patients greater than 135 kg in weight. 3. Patients with a platelet count less than 30,000/mm3 4. Active internal bleeding or at increased risk for bleeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Data | 9 Months |
Secondary
| Measure | Time frame |
|---|---|
| All cause mortality data. | 9 Months |
| To determine the final disposition of sepsis patients treated with drotrecogin alfa (activated)(that is, patient location at discharge from study hospital or 90 days). | 9 Months |
Countries
Belgium
Outcome results
None listed