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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00568737




Registration number
NCT00568737
Ethics application status
Date submitted
5/12/2007
Date registered
6/12/2007
Date last updated
6/12/2007

Titles & IDs
Public title
The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death
Scientific title
Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Early Stage Severe Sepsis
Secondary ID [1] 0 0
F1K-MC-EVCM
Secondary ID [2] 0 0
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
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)
Drotrecogin Alfa (activated)

Treatment: Drugs: Placebo
0.9% sodium chloride
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy
Timepoint [1] 0 0
20 months
Secondary outcome [1] 0 0
Safety
Timepoint [1] 0 0
20 months

Eligibility
Key inclusion criteria
* Adult patients with recent onset of severe sepsis or presence of a suspected or proven infection, and at least one induced organ dysfunction.
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) under the applicable label in the investigative site country.
* Are contraindicated for treatment with drotrecogin alfa (activated) under the applicable label in the investigative site country.
* Platelet count less than 30,000/mm3.

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
1/02/2005
Sample size
Target
Accrual to date
Final
2640
Recruitment in Australia
Recruitment state(s)
ACT,NSW,TAS,VIC,WA
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. - Garran
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. - Camperdown
Recruitment hospital [3] 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. - Kingswood
Recruitment hospital [4] 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. - Randwick
Recruitment hospital [5] 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 hospital [6] 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. - Box Hill
Recruitment hospital [7] 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. - Fitzroy
Recruitment hospital [8] 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. - Prahan
Recruitment hospital [9] 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. - Nedlands
Recruitment postcode(s) [1] 0 0
- Garran
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Kingswood
Recruitment postcode(s) [4] 0 0
- Randwick
Recruitment postcode(s) [5] 0 0
- Hobart
Recruitment postcode(s) [6] 0 0
- Box Hill
Recruitment postcode(s) [7] 0 0
- Fitzroy
Recruitment postcode(s) [8] 0 0
- Prahan
Recruitment postcode(s) [9] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad De Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Cordoba
Country [4] 0 0
Austria
State/province [4] 0 0
Innsbuck
Country [5] 0 0
Austria
State/province [5] 0 0
Wein
Country [6] 0 0
Belgium
State/province [6] 0 0
Arlon
Country [7] 0 0
Belgium
State/province [7] 0 0
Brussels
Country [8] 0 0
Belgium
State/province [8] 0 0
Bruxelles
Country [9] 0 0
Belgium
State/province [9] 0 0
Gent
Country [10] 0 0
Belgium
State/province [10] 0 0
Liege
Country [11] 0 0
Belgium
State/province [11] 0 0
Ottignies
Country [12] 0 0
Brazil
State/province [12] 0 0
PR
Country [13] 0 0
Brazil
State/province [13] 0 0
Rio De Janerio
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Brazil
State/province [15] 0 0
SC
Country [16] 0 0
Brazil
State/province [16] 0 0
Porto Algre
Country [17] 0 0
Brazil
State/province [17] 0 0
Salvador
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Nova Scotia
Country [21] 0 0
Canada
State/province [21] 0 0
Ontario
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
Country [23] 0 0
Canada
State/province [23] 0 0
Saskatchewan
Country [24] 0 0
Chile
State/province [24] 0 0
Santiago
Country [25] 0 0
Czech Republic
State/province [25] 0 0
Brno
Country [26] 0 0
Czech Republic
State/province [26] 0 0
Hradec Kralove
Country [27] 0 0
Czech Republic
State/province [27] 0 0
Olomouc
Country [28] 0 0
Czech Republic
State/province [28] 0 0
Plzen
Country [29] 0 0
Czech Republic
State/province [29] 0 0
Praha 8
Country [30] 0 0
Denmark
State/province [30] 0 0
S
Country [31] 0 0
Denmark
State/province [31] 0 0
Aalborg
Country [32] 0 0
Denmark
State/province [32] 0 0
Esbjerg
Country [33] 0 0
Denmark
State/province [33] 0 0
Holbaek
Country [34] 0 0
Denmark
State/province [34] 0 0
Hvidovre
Country [35] 0 0
Denmark
State/province [35] 0 0
Roskilde
Country [36] 0 0
Denmark
State/province [36] 0 0
Sonderborg
Country [37] 0 0
Denmark
State/province [37] 0 0
Viborg
Country [38] 0 0
Egypt
State/province [38] 0 0
Cairo
Country [39] 0 0
Finland
State/province [39] 0 0
Hus
Country [40] 0 0
Finland
State/province [40] 0 0
Jyvaskyla
Country [41] 0 0
Finland
State/province [41] 0 0
Kuopio
Country [42] 0 0
Finland
State/province [42] 0 0
Oulu
Country [43] 0 0
Finland
State/province [43] 0 0
Turku
Country [44] 0 0
France
State/province [44] 0 0
Argenteuil
Country [45] 0 0
France
State/province [45] 0 0
Aulnay-Sous-Bois
Country [46] 0 0
France
State/province [46] 0 0
Besancon
Country [47] 0 0
France
State/province [47] 0 0
Corbeil Essonnes
Country [48] 0 0
France
State/province [48] 0 0
Dijon
Country [49] 0 0
France
State/province [49] 0 0
Gleize

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

Ethics approval
Ethics application status

Summary
Brief summary
Adult Patients with Severe Sepsis
Trial website
https://clinicaltrials.gov/study/NCT00568737
Trial related presentations / publications
Laterre PF, Macias WL, Janes J, Williams MD, Nelson DR, Girbes AR, Dhainaut JF, Abraham E. Influence of enrollment sequence effect on observed outcomes in the ADDRESS and PROWESS studies of drotrecogin alfa (activated) in patients with severe sepsis. Crit Care. 2008;12(5):R117. doi: 10.1186/cc7011. Epub 2008 Sep 11.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00568737