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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

474

participants targeted

Target at P50-P75 for phase_3 sepsis

Timeline

Completed

Started Nov 2002

Geographic Reach

11 countries

49 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.4 years study duration

Study Start

First participant enrolled

November 1, 2002

Completed

12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2002

Completed

1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2002

Completed

2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed

Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

November 13, 2002

Last Update Submit

November 15, 2007

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

All cause mortality data
3 Years
The effects of drotrecogin alfa (activated) on individual organ dysfunction
3 Years
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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Drotrecogin alfa (activated)

2

PLACEBO COMPARATOR

0.9% sodium chloride

Drug: Placebo

Interventions

Drotrecogin alfa (activated)DRUG

Also known as: LY203638, Xigris

PlaceboDRUG

Eligibility Criteria

AgeUp to 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (49)

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.

Birmingham, Alabama, United States

Location

Tucson, Arizona, United States

Location

Tuscon, Arizona, United States

Location

Madera, California, United States

Location

San Diego, California, United States

Location

Washington D.C., District of Columbia, United States

Location

Boise, Idaho, United States

Location

Chicago, Illinois, United States

Location

Oak Lawn, Illinois, United States

Location

Park Ridge, Illinois, United States

Location

Indianapolis, Indiana, United States

Location

Ann Arbor, Michigan, United States

Location

Kansas City, Missouri, United States

Location

Albany, New York, United States

Location

New Hyde Park, New York, United States

Location

New York, New York, United States

Location

Oklahoma City, Oklahoma, United States

Location

Hershey, Pennsylvania, United States

Location

Pittsburgh, Pennsylvania, United States

Location

Charleston, South Carolina, United States

Location

Nashville, Tennessee, United States

Location

San Antonio, Texas, United States

Location

Falls Church, Virginia, United States

Location

Westmead, New South Wales, Australia

Location

Hobart, Tasmania, Australia

Location

Santiago, Chile

Location

Amiens, France

Location

Bordeaux, France

Location

Le Kremlin-Bicêtre, France

Location

Lyon, France

Location

Marseille, France

Location

Nantes, France

Location

Toulouse, France

Location

Erlangen, Germany

Location

Magdeburg, Germany

Location

Würzburg, Germany

Location

Milan, Italy

Location

Mexico City, Benito Juarez, Mexico

Location

Lublin, Poland

Location

Banska, Bystrica, Slovakia

Location

Bratislava, Slovakia

Location

Zurich, Switzerland

Location

Southhampton, Hants, United Kingdom

Location

Bloomsbury, London, United Kingdom

Location

Paddington, London, United Kingdom

Location

Birmingham, United Kingdom

Location

London, United Kingdom

Location

Manchester, United Kingdom

Location

Southhampton, United Kingdom

Location

Related Publications (2)

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.
PMID: 24108117DERIVED
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.
PMID: 17350452DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

drotrecogin alfa activated

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

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
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

November 13, 2002

First Posted

November 14, 2002

Study Start

November 1, 2002

Study Completion

April 1, 2005

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

GB(7)DE(3)IT(1)FR(7)ME(1)PL(1)AU(2)CL(1)SL(2)US(23)CH(1)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (49)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (49)

Related Publications (2)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations