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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis
Secondary ID [1] 0 0
F1K-MC-EVBP
Secondary ID [2] 0 0
6716
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Drotrecogin alfa (activated)
Treatment: Drugs - Placebo

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

Placebo Comparator: 2 - 0.9% sodium chloride


Treatment: Drugs: Drotrecogin alfa (activated)


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
That drotrecogin alfa (activated) compared with placebo reduces severe-sepsis-induced organ dysfunction
Timepoint [1] 0 0
3 Years
Secondary outcome [1] 0 0
All cause mortality data
Timepoint [1] 0 0
3 Years
Secondary outcome [2] 0 0
The effects of drotrecogin alfa (activated) on individual organ dysfunction
Timepoint [2] 0 0
3 Years
Secondary outcome [3] 0 0
Amputation reduction (at or above the wrist, at or above the ankle, face, and genitals)in pediatric patients with Neisseria meningitidis
Timepoint [3] 0 0
3 Years
Secondary outcome [4] 0 0
Demonstrate that drotrecogin alfa (activated) has antithrombotic and anti-inflammatory properties.
Timepoint [4] 0 0
3 Years

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.
Minimum age
No limit
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2005
Sample size
Target
Accrual to date
Final
474
Recruitment in Australia
Recruitment state(s)
NSW,TAS
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment postcode(s) [2] 0 0
- Hobart
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
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United States of America
State/province [4] 0 0
District of Columbia
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United States of America
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Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
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Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
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United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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United States of America
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Virginia
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Chile
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Santiago de Chile
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France
State/province [18] 0 0
Amiens Cedex
Country [19] 0 0
France
State/province [19] 0 0
Amiens
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France
State/province [20] 0 0
Bordeaux
Country [21] 0 0
France
State/province [21] 0 0
Le Kremlin-Bicetre
Country [22] 0 0
France
State/province [22] 0 0
Lyon Cedex 03
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France
State/province [23] 0 0
Lyon
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France
State/province [24] 0 0
Marseille
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France
State/province [25] 0 0
Nantes
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France
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Toulouse
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Germany
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Erlangen
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Germany
State/province [28] 0 0
Magdeburg
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Germany
State/province [29] 0 0
Wurzburg
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Italy
State/province [30] 0 0
Milano
Country [31] 0 0
Mexico
State/province [31] 0 0
Benito Juarez
Country [32] 0 0
Poland
State/province [32] 0 0
Lublin
Country [33] 0 0
Slovakia
State/province [33] 0 0
Bystrica
Country [34] 0 0
Slovakia
State/province [34] 0 0
Bratislava
Country [35] 0 0
Switzerland
State/province [35] 0 0
Zurich
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United Kingdom
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Hants
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United Kingdom
State/province [37] 0 0
London
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United Kingdom
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Birmingham
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United Kingdom
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Manchester
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United Kingdom
State/province [40] 0 0
Southhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00049764
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries