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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/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
Treatment: Drugs - Drotrecogin alfa (activated)

Treatment: Drugs: Drotrecogin alfa (activated)
Intervention code [1] 0 0
Treatment: Drugs
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
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- Perth
Recruitment outside Australia
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Idaho
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Illinois
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Indiana
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Iowa
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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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Michigan
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North Dakota
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Wisconsin
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Germany
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Halle
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Germany
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Germany
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Hannover
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Germany
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Germany
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Lubeck
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Germany
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Germany
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Munchen
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Germany
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Regensburg
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Germany
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Reutlingen
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Germany
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Tubingen
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India
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Andhara Pradesh
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India
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Delhi
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India
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India
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India
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UP
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India
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CT
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Italy
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Milano
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Italy
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MI
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Italy
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PD
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Italy
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Italy
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Italy
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Bolzano
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Como
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Italy
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Genova
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Italy
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Lecce
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Italy
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Lecco
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Italy
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Padova
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Italy
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Palermo
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Italy
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Pavia
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Italy
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Pesaro
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Italy
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Pisa
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Italy
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Roma
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Italy
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Sassari
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Italy
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Siena
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Italy
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Treviglio
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Italy
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Trieste
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Italy
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Varese
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Lebanon
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Beirut
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Mexico
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DF
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Mexico
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Nuevo Leon
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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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Netherlands
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Breda
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Netherlands
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Den Bosch
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Netherlands
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Tilburg
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New Zealand
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Canterbury
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New Zealand
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Auckland
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New Zealand
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Hamilton
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New Zealand
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Hastings
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Norway
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Alesund
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Drammen
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Norway
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Nordbyhagen
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Oslo
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Norway
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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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Russian Federation
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Russia
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Russian Federation
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Smolensk
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Jeddah
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Saudi Arabia
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Riyadh
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Singapore
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Singapore
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Slovakia
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Bratislava
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Slovakia
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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
Severe sepsis is defined as a systemic inflammatory response syndrome that results from
infection and is associated with acute organ dysfunction. It usually results from bacterial
infections, but it may occur in response to other pathogens, such as fungi, viruses, and
parasites.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00045760
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
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Phone 0 0
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Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00045760