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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00049764
Registration number
NCT00049764
Ethics application status
Date submitted
13/11/2002
Date registered
14/11/2002
Date last updated
20/11/2007
Titles & IDs
Public title
Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
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Scientific title
Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
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Secondary ID [1]
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F1K-MC-EVBP
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Secondary ID [2]
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6716
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sepsis
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Injuries and Accidents
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Poisoning
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Blood
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Other blood disorders
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Infection
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental: 1 - 24 microgram/kg/hr for 96 hours (+ or - 1 hour)
Placebo comparator: 2 - 0.9% sodium chloride
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
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Assessment method [1]
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Timepoint [1]
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3 Years
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Secondary outcome [1]
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All cause mortality data
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Assessment method [1]
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Timepoint [1]
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3 Years
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Secondary outcome [2]
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The effects of drotrecogin alfa (activated) on individual organ dysfunction
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Assessment method [2]
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Timepoint [2]
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3 Years
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Secondary outcome [3]
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Amputation reduction (at or above the wrist, at or above the ankle, face, and genitals)in pediatric patients with Neisseria meningitidis
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Assessment method [3]
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Timepoint [3]
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3 Years
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Secondary outcome [4]
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Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.
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Assessment method [4]
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Timepoint [4]
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3 Years
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Eligibility
Key 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.
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Minimum age
No limit
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Maximum age
17
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2005
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Sample size
Target
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Accrual to date
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Final
474
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Recruitment in Australia
Recruitment state(s)
NSW,TAS
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Recruitment hospital [1]
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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. - Westmead
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Recruitment hospital [2]
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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. - Hobart
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Recruitment postcode(s) [1]
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- Westmead
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Recruitment postcode(s) [2]
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- Hobart
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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District of Columbia
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Idaho
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Illinois
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Indiana
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Michigan
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Santiago de Chile
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France
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France
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Amiens
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France
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Lyon Cedex 03
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France
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Lyon
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Nantes
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Toulouse
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Milano
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Benito Juarez
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Lublin
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Slovakia
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Bystrica
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Manchester
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United Kingdom
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Southhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00049764
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Trial related presentations / publications
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. 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.
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00049764
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