Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00049764

Purpose

The purposes of this study are to determine:

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).
Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis.
The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.

Condition	Intervention	Phase
Sepsis	Drug: Drotrecogin alfa (activated) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

Drug Information available for: Drotrecogin alfa

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction [ Time Frame: 3 Years ]

Secondary Outcome Measures:

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 ]

Enrollment:	474
Study Start Date:	November 2002
Study Completion Date:	April 2005

Arms	Assigned Interventions
Experimental: 1 24 microgram/kg/hr for 96 hours (+ or - 1 hour)	Drug: Drotrecogin alfa (activated) Other Names: LY203638 Xigris
Placebo Comparator: 2 0.9% sodium chloride	Drug: Placebo

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.

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049764

Show 51 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nadel S, Goldstein B, Williams MD, Dalton H, Peters M, Macias WL, Abd-Allah SA, Levy H, Angle R, Wang D, Sundin DP, Giroir B; REsearching severe Sepsis and Organ dysfunction in children: a gLobal perspective (RESOLVE) study group. Drotrecogin alfa (activated) in children with severe sepsis: a multicentre phase III randomised controlled trial. Lancet. 2007 Mar 10;369(9564):836-43.

ClinicalTrials.gov Identifier:	NCT00049764 History of Changes
Other Study ID Numbers:	6716, F1K-MC-EVBP
Study First Received:	November 13, 2002
Last Updated:	November 15, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Drotrecogin alfa activated
Protein C
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012