Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis

Phase 3

Completed

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.

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) and/or 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.

Recruitment & Eligibility

Inclusion Criteria

Suspected or proven acute infection.
Abnormally high or low core body temperature
Cardiovascular dysfunction which requires the use of vasoactive drugs (such as, dopamine, dobutamine, epinephrine) and is the result of severe sepsis.
Respiratory dysfunction which requires the use of mechanical ventilation and is the result of severe sepsis.

Exclusion Criteria

Patients at increased risk of bleeding.
Patients at high risk for an intracranial bleed.
Patients who have undergone a bone marrow transplant.
Patients with end-stage renal disease.
Patients whose family or primary care physician is unwilling to allow transfusion of blood products.

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
That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction	3 Years

Secondary Outcome Measures

Name	Time	Method
Amputation reduction (at or above the wrist, at or above the ankle, face, and genitals)in pediatric patients with Neisseria meningitidis	3 Years
Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.	3 Years
All cause mortality data	3 Years
The effects of drotrecogin alfa (activated) on individual organ dysfunction	3 Years

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.
🇬🇧
Southhampton, United Kingdom
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.
🇬🇧Southhampton, United Kingdom

CompletedPhase 3

Posted 9/19/2005

Updated 10/12/2007