Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049764
Status:
COMPLETED
Last Update Posted:
2007-11-20
First Post:
2002-11-13
Brief Title:
Investigation of the Efficacy and Safety of Drotrecogin Alfa Activated in Pediatric Severe Sepsis
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
Investigation of the Efficacy and Safety of Drotrecogin Alfa Activated in Pediatric Severe Sepsis
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this study are to determine
1 Whether drotrecogin alfa activated helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa activated
2 Whether drotrecogin alfa activated minimizes long term disabilities associated with severe sepsis
3 The side effects that might be associated with drotrecogin alfa activated administration to children with severe sepsis
1 Whether drotrecogin alfa activated helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa activated
2 Whether drotrecogin alfa activated minimizes long term disabilities associated with severe sepsis
3 The side effects that might be associated with drotrecogin alfa activated administration to children with severe sepsis
Detailed Description:
The primary objective was to demonstrate that drotrecogin alfa activated compared with placebo reduced severe-sepsis-induced organ dysfunction as assessed by time to complete resolution of a composite of cardiovascular respiratory and renal organ failure in pediatric patients with severe sepsis
Secondary objectives included 1 to assess whether treatment with drotrecogin alfa activated reduced 28-day all-cause mortality in pediatric patients with severe sepsis compared with placebo patients 2 to evaluate the effects of drotrecogin alfa activated on individual organ dysfunction cardiovascular respiratory renal hepatic hematologic neurologic and cutaneous 3 to demonstrate that drotrecogin alfa activated improved patient outcome as assessed by the Pediatric Overall Performance Category POPC scale 4 to demonstrate that drotrecogin alfa activated reduced major amputations at or above the wrist at or above the ankle face and genitals in pediatric patients with Neisseria meningitidis proven or suspected andor purpura fulminans 5 to demonstrate that drotrecogin alfa activated had antithrombotic and anti-inflammatory properties The safety objective was to evaluate whether drotrecogin alfa activated had an acceptable safety profile when administered to pediatric patients with severe sepsis
Secondary objectives included 1 to assess whether treatment with drotrecogin alfa activated reduced 28-day all-cause mortality in pediatric patients with severe sepsis compared with placebo patients 2 to evaluate the effects of drotrecogin alfa activated on individual organ dysfunction cardiovascular respiratory renal hepatic hematologic neurologic and cutaneous 3 to demonstrate that drotrecogin alfa activated improved patient outcome as assessed by the Pediatric Overall Performance Category POPC scale 4 to demonstrate that drotrecogin alfa activated reduced major amputations at or above the wrist at or above the ankle face and genitals in pediatric patients with Neisseria meningitidis proven or suspected andor purpura fulminans 5 to demonstrate that drotrecogin alfa activated had antithrombotic and anti-inflammatory properties The safety objective was to evaluate whether drotrecogin alfa activated had an acceptable safety profile when administered to pediatric patients with severe sepsis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| F1K-MC-EVBP | None | None | None |