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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00049764
First received: November 13, 2002
Last updated: November 15, 2007
Last verified: November 2007

November 13, 2002
November 15, 2007
November 2002
Not Provided
That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction [ Time Frame: 3 Years ]
Not Provided
Complete list of historical versions of study NCT00049764 on ClinicalTrials.gov Archive Site
  • All cause mortality data [ Time Frame: 3 Years ]
  • The effects of drotrecogin alfa (activated) on individual organ dysfunction [ Time Frame: 3 Years ]
  • Amputation reduction (at or above the wrist, at or above the ankle, face, and genitals)in pediatric patients with Neisseria meningitidis [ Time Frame: 3 Years ]
  • Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties. [ Time Frame: 3 Years ]
Not Provided
Not Provided
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Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Sepsis
  • Drug: Drotrecogin alfa (activated)
    Other Names:
    • LY203638
    • Xigris
  • Drug: Placebo
  • Experimental: 1
    24 microgram/kg/hr for 96 hours (+ or - 1 hour)
    Intervention: Drug: Drotrecogin alfa (activated)
  • Placebo Comparator: 2
    0.9% sodium chloride
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
474
April 2005
Not Provided

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.
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Chile,   France,   Germany,   Italy,   Mexico,   Poland,   Slovakia,   Switzerland,   United Kingdom
 
NCT00049764
6716, F1K-MC-EVBP
Yes
Not Provided
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP