Brief Summary

Adult Patients with Severe Sepsis

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

2,640

participants targeted

Target at P75+ for phase_3 sepsis

Timeline

Completed

Started Nov 2002

Geographic Reach

11 countries

61 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.3 years study duration

Study Start

First participant enrolled

November 1, 2002

Completed

2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed

2.8 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2007

Completed

1 day until next milestone

First Posted

Study publicly available on registry

December 6, 2007

Completed

Last Updated

December 6, 2007

Status Verified

December 1, 2007

First QC Date

December 5, 2007

Last Update Submit

December 5, 2007

Conditions

Sepsis

Keywords

Severe Sepsis

Outcome Measures

Primary Outcomes (1)

Efficacy
20 months

Secondary Outcomes (1)

Safety
20 months

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Drotrecogin alfa (activated)

2

PLACEBO COMPARATOR

0.9% sodium chloride

Drug: Placebo

Interventions

Drotrecogin alfa (activated)DRUG

Drotrecogin Alfa (activated)

Also known as: LY203638, Xigris

PlaceboDRUG

0.9% sodium chloride

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adult patients with recent onset of severe sepsis or presence of a suspected or proven infection, and at least one induced organ dysfunction.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eli Lilly and Companylead

Study Sites (70)

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.

Haedi, Buenos Aires, Argentina

Location

Monte Grande, Buenos Aires, Argentina

Location

Rosario - Santa Fe, Buenos Aires, Argentina

Location

Ciudad de Buenos Aires, Buenos Aires F.D., Argentina

Location

Córdoba, Córdoba Province, Argentina

Location

Buenos Aires, Argentina

Location

Garran, Australian Capital Territory, Australia

Location

Camperdown, New South Wales, Australia

Location

Kingswood, New South Wales, Australia

Location

Randwick, New South Wales, Australia

Location

Hobart, Tasmania, Australia

Location

Box Hill, Victoria, Australia

Location

Fitzroy, Victoria, Australia

Location

Prahan, Victoria, Australia

Location

Nedlands, Western Australia, Australia

Location

Innsbruck, Innsbuck, Austria

Location

Wein, Wein, Austria

Location

Arlon, Arlon, Belgium

Location

Brussels, Brussels Capital, Belgium

Location

Ghent, Gent, Belgium

Location

Liège, Liege, Belgium

Location

Ottignies, Ottignies, Belgium

Location

Curitiba, Paraná, Brazil

Location

Porto Algre, Porto Algre, Brazil

Location

Rio de Janeiro, Rio de Janerio, Brazil

Location

Salvador, Salvador, Brazil

Location

Florianópolis, Santa Catarina, Brazil

Location

Sao Jose Rio Preto, São Paulo, Brazil

Location

Calgary, Alberta, Canada

Location

Edmonton, Alberta, Canada

Location

New Westminster, British Columbia, Canada

Location

Vancouver, British Columbia, Canada

Location

Halifax, Nova Scotia, Canada

Location

Brampton, Ontario, Canada

Location

Greater Sudbury, Ontario, Canada

Location

Kingston, Ontario, Canada

Location

Ottawa, Ontario, Canada

Location

Toronto, Ontario, Canada

Location

Windsor, Ontario, Canada

Location

Greenfield Park, Quebec, Canada

Location

Sherbrooke, Quebec, Canada

Location

Regina, Saskatchewan, Canada

Location

Saskatoon, Saskatchewan, Canada

Location

Las Condes, Santiago Metropolitan, Chile

Location

Santiago, Santiago Metropolitan, Chile

Location

Brno, Brno, Czechia

Location

Hradec Králové, Hradec Kralove, Czechia

Location

Olomouc, Olomouc, Czechia

Location

Pilsen, Plzen, Czechia

Location

Prague, Praha 8, Czechia

Location

Aalborg, Aalborg, Denmark

Location

Esbjerg, Esbjerg, Denmark

Location

Holbæk, Holbaek, Denmark

Location

Hvidovre, Hvidovre, Denmark

Location

Roskilde, Roskilde, Denmark

Location

Sønderborg, Sonderborg, Denmark

Location

Copenhagen, S, Denmark

Location

Viborg, Viborg, Denmark

Location

Cairo, Cairo Governorate, Egypt

Location

Helsinki, Hus, Finland

Location

Jyväskylä, Jyvaskyla, Finland

Location

Kuopio, Kuopio, Finland

Location

Oulu, Oulu, Finland

Location

Turku, Turku, Finland

Location

Argenteuil, Argenteuil, France

Location

Aulnay-sous-Bois, Aulnay-Sous-Bois, France

Location

Besançon, Besancon, France

Location

Dijon, Dijon, France

Location

Gleizé, Gleize, France

Location

Corbeil-Essonnes, France

Location

Related Publications (1)

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.
PMID: 18786266DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

drotrecogin alfa activated

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

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)
Eli Lilly and Company
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 6, 2007

Study Start

November 1, 2002

Study Completion

February 1, 2005

Last Updated

December 6, 2007

Record last verified: 2007-12

Locations

AU(2)FR(6)EG(1)CA(15)AR(6)BE(5)BR(6)DK(8)CL(2)FI(5)CZ(5)

The Study of Drotrecogin Alfa (Activated) in Adult Patients With Severe Sepsis at a Low Risk of Death

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (70)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (70)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations