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

Primary Purpose

Sepsis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Drotrecogin alfa (activated)

Placebo

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

24 microgram/kg/hr for 96 hours (+ or - 1 hour)

0.9% sodium chloride

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All cause mortality data

The effects of drotrecogin alfa (activated) on individual organ dysfunction

Amputation reduction (at or above the wrist, at or above the ankle, face, and genitals)in pediatric patients with Neisseria meningitidis

Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.

Full Information

NCT ID

NCT00049764

First Posted

November 13, 2002

Last Updated

November 15, 2007

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00049764

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2007

Overall Recruitment Status

Completed

Study Start Date

November 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

474 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

24 microgram/kg/hr for 96 hours (+ or - 1 hour)

Arm Title

Arm Type

Placebo Comparator

Arm Description

0.9% sodium chloride

Intervention Type

Drug

Intervention Name(s)

Drotrecogin alfa (activated)

Other Intervention Name(s)

LY203638, Xigris

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

3 Years

Secondary Outcome Measure Information:

Title

All cause mortality data

Time Frame

3 Years

Title

The effects of drotrecogin alfa (activated) on individual organ dysfunction

Time Frame

3 Years

Title

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

Title

Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.

Time Frame

3 Years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Birmingham

State/Province

Alabama

Country

United States

Facility Name

City

Tucson

State/Province

Arizona

Country

United States

Facility Name

City

Tuscon

State/Province

Arizona

Country

United States

Facility Name

City

Madera

State/Province

California

Country

United States

Facility Name

City

San Diego

State/Province

California

Country

United States

Facility Name

City

Washington DC

State/Province

District of Columbia

Country

United States

Facility Name

City

Boise

State/Province

Idaho

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

Country

United States

Facility Name

City

Oak Lawn

State/Province

Illinois

Country

United States

Facility Name

City

Park Ridge

State/Province

Illinois

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

City

Ann Arbor

State/Province

Michigan

Country

United States

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Kansas City

State/Province

Missouri

Country

United States

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Albany

State/Province

New York

Country

United States

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New Hyde Park

State/Province

New York

Country

United States

Facility Name

City

New York

State/Province

New York

Country

United States

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Oklahoma City

State/Province

Oklahoma

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United States

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Hershey

State/Province

Pennsylvania

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United States

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Pittsburgh

State/Province

Pennsylvania

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United States

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Charleston

State/Province

South Carolina

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United States

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Nashville

State/Province

Tennessee

Country

United States

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San Antonio

State/Province

Texas

Country

United States

Facility Name

City

Falls Church

State/Province

Virginia

Country

United States

Facility Name

City

Westmead

State/Province

New South Wales

Country

Australia

Facility Name

City

Hobart

State/Province

Tasmania

Country

Australia

Facility Name

City

Santiago de Chile

Country

Chile

Facility Name

City

Amiens Cedex

Country

France

Facility Name

City

Amiens

Country

France

Facility Name

City

Bordeaux

Country

France

Facility Name

City

Le Kremlin-Bicetre

Country

France

Facility Name

City

Lyon Cedex 03

Country

France

Facility Name

City

Lyon

Country

France

Facility Name

City

Marseille

Country

France

Facility Name

City

Nantes

Country

France

Facility Name

City

Toulouse

Country

France

Facility Name

City

Erlangen

Country

Germany

Facility Name

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Magdeburg

Country

Germany

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City

Wurzburg

Country

Germany

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Milano

Country

Italy

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Mexico City

State/Province

Benito Juarez

Country

Mexico

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Lublin

Country

Poland

Facility Name

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Banska

State/Province

Bystrica

Country

Slovakia

Facility Name

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Bratislava

Country

Slovakia

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City

Zurich

Country

Switzerland

Facility Name

City

Southhampton

State/Province

Hants

Country

United Kingdom

Facility Name

City

Bloomsbury

State/Province

London

Country

United Kingdom

Facility Name

City

Paddington

State/Province

London

Country

United Kingdom

Facility Name

City

Birmingham

Country

United Kingdom

Facility Name

City

London

Country

United Kingdom

Facility Name

City

Manchester

Country

United Kingdom

Facility Name

City

Southhampton

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

24108117

Citation

Farris RW, Weiss NS, Zimmerman JJ. Functional outcomes in pediatric severe sepsis: further analysis of the researching severe sepsis and organ dysfunction in children: a global perspective trial. Pediatr Crit Care Med. 2013 Nov;14(9):835-42. doi: 10.1097/PCC.0b013e3182a551c8.

Results Reference

derived

PubMed Identifier

17350452

Citation

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):836-843. doi: 10.1016/S0140-6736(07)60411-5.

Results Reference

derived

Learn more about this trial

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

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