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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00045760




Registration number
NCT00045760
Ethics application status
Date submitted
9/09/2002
Date registered
10/09/2002
Date last updated
20/07/2006

Titles & IDs
Public title
The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients With Severe Sepsis
Scientific title
Secondary ID [1] 0 0
F1K-MC-EVCL
Secondary ID [2] 0 0
7252, 6669
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
* Adult patients with severe sepsis.
* Presence of a suspected or proven infection.
* One or more sepsis-associated organ failure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Are indicated for the treatment with drotrecogin alfa (activated) in the investigative site country.
* Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
* Platelet count <30,000/mm3.
* Are receiving therapeutic heparin.

Study design
Purpose of the study
Treatment
Allocation to intervention
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?



Intervention assignment
Other design features
Phase
Phase 4
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
1/09/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Garran
Recruitment hospital [2] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Camperdown
Recruitment hospital [3] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Kingswood
Recruitment hospital [4] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Liverpool
Recruitment hospital [5] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Randwick
Recruitment hospital [6] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - St. Leonards
Recruitment hospital [7] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Tiwi
Recruitment hospital [8] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Douglas
Recruitment hospital [9] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Herston
Recruitment hospital [10] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Adelaide
Recruitment hospital [11] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Bedford Park
Recruitment hospital [12] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Hobart
Recruitment hospital [13] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Box Hill
Recruitment hospital [14] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Dandenong
Recruitment hospital [15] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Fitzroy
Recruitment hospital [16] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Footscray
Recruitment hospital [17] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Heidelberg
Recruitment hospital [18] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Parkville
Recruitment hospital [19] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Prahran
Recruitment hospital [20] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Nedlands
Recruitment hospital [21] 0 0
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician. - Perth
Recruitment postcode(s) [1] 0 0
- Garran
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- Camperdown
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- Kingswood
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- Liverpool
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- Randwick
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- St. Leonards
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- Tiwi
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- Douglas
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- Herston
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- Adelaide
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- Bedford Park
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- Hobart
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- Box Hill
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- Dandenong
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- Fitzroy
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- Footscray
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- Heidelberg
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- Parkville
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- Prahran
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- Nedlands
Recruitment postcode(s) [21] 0 0
- Perth
Recruitment outside Australia
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Illinois
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Indiana
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Kansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Massachusetts
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Michigan
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Italy
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Trieste
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Varese
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DF
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Mexico
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Mexico
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Mexico City
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Netherlands
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Apeldoorn
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Breda
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Netherlands
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Netherlands
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Auckland
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Alesund
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Trondheim
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Romania
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Sector 2
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Romania
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Bucharest
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Russia
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Smolensk
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Jeddah
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Riyadh
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Bratislava
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Kosice
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South Africa
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Northampton

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

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/NCT00045760