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Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock

Primary Purpose

Sepsis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Drotrecogin alfa (activated)

Placebo

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Septic shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Must be 18 years or older
Must have evidence of infection
Must have systemic inflammatory response syndrome (SIRS)
Must have vasopressor-dependent septic shock

Exclusion Criteria:

Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the start of study drug
Have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of the study drug infusion
Have single organ dysfunction and recent surgery (within 30 days of study entry)
Have had surgery performed within the 12-hour period immediately preceding the study drug infusion, or are postoperative with evidence of active bleeding, or have planned or anticipated surgery during the infusion period
Are not expected to survive 28 days given their preexisting uncorrectable medical condition

Sites / Locations

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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.
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Drotrecogin alfa (activated)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

28-Day All-Cause Mortality

Expressed as percentage of participants who died from any cause at Day 28 endpoint.

Secondary Outcome Measures

28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency

Expressed as percentage of participants who died from any cause at Day 28 endpoint. Participants with severe protein C deficiency are those who had a protein C level ≤ half the lower limit of normal (LLN) (≤40%).

Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing cardiovascular dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.

Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing respiratory dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.

Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

Scores range from 0 (normal) to 4 (organ failure) with an increasing score indicating increasing renal dysfunction. A non-surviving participant receives a score of 4 (worst score) for the day of death and every day thereafter.

90-Day Mortality

Expressed as percentage of participants who died from any cause at Day 90 endpoint.

180-Day Mortality

Expressed as percentage of participants who died from any cause at Day 180 endpoint.

Median Survival Time

EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180

EQ-5D VAS assesses caregiver's impression of participant's overall health state. Scores range from 0 (worst health state) to 100 (best health state), with higher scores indicating a better health state.

EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180

The EQ-5D is used to assess participant's overall health. Consists of 5 items: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has 3 severity levels (no, some, severe problems). Calculated from EQ-5D, total scores (United States [US] Index Score) range from 0 (worst quality of life) to 1.00 (best quality of life).

Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180

SF-12 was used as an instrument to measure participants' physical wellbeing (physical component) and mental wellbeing (mental component). Scores for each component range from 0-100, with 0= lowest wellbeing, and 100=highest wellbeing.

Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint

Full Information

NCT ID

NCT00604214

First Posted

January 24, 2008

Last Updated

August 20, 2012

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00604214

Brief Title

Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock

Official Title

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of Drotrecogin Alfa (Activated) Administered as a Continuous 96-hr Infusion to Adult Patients With Septic Shock

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this placebo-controlled study is to determine if drotrecogin alfa (activated) treatment provides significant mortality reduction improvement in patients with septic shock compared with placebo treatment in patients receiving the current standard of care for septic shock. This study will also assess the effectiveness of drotrecogin alfa (activated) in reducing 28-day mortality in patients with septic shock and concomitant severe protein C deficiency.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

Keywords

Sepsis, Septic shock

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1696 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drotrecogin alfa (activated)

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Drotrecogin alfa (activated)

Other Intervention Name(s)

LY203638, Xigris

Intervention Description

24 microgram/kilogram/hour, intravenous, 96 hours (hr)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

0.9% sodium chloride, intravenous, 96 hours

Primary Outcome Measure Information:

Title

28-Day All-Cause Mortality

Description

Expressed as percentage of participants who died from any cause at Day 28 endpoint.

Time Frame

Day 28

Secondary Outcome Measure Information:

Title

28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency

Description

Time Frame

Day 28

Title

Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

Description

Time Frame

Day 1 through Day 28

Title

Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

Description

Time Frame

Day 1 through Day 28

Title

Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28

Description

Time Frame

Day 1 through Day 28

Title

90-Day Mortality

Description

Expressed as percentage of participants who died from any cause at Day 90 endpoint.

Time Frame

Day 90

Title

180-Day Mortality

Description

Expressed as percentage of participants who died from any cause at Day 180 endpoint.

Time Frame

Day 180

Title

Median Survival Time

Time Frame

Day 180

Title

EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180

Description

Time Frame

Baseline and Days 28 and 90 and 180

Title

EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180

Description

Time Frame

Baseline and Days 28 and 90 and 180

Title

Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180

Description

Time Frame

Baseline and Days 28 and 90 and 180

Title

Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint

Time Frame

Baseline through Day 28

Other Pre-specified Outcome Measures:

Title

Percentage of Participants With Serious Bleeding Events Within System Organ Class Any Time From Baseline Through Day 28

Description

Percentage of participants who experienced serious bleeding events are reported by System Organ Class (SOC) term based on MedDRA 14.0. For a bleeding to qualify as a serious event, it would have to meet the standard definition of a serious adverse event or be a central nervous system bleeding or a bleeding event that lead to administration of ≥3 units packed red blood cells/day for 2 consecutive days.

Time Frame

Baseline through Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must be 18 years or older Must have evidence of infection Must have systemic inflammatory response syndrome (SIRS) Must have vasopressor-dependent septic shock Exclusion Criteria: Have received vasopressor therapy (at any dose) for greater than 24 hours prior to the start of study drug Have sepsis-induced organ dysfunction for greater than 36 hours prior to the start of the study drug infusion Have single organ dysfunction and recent surgery (within 30 days of study entry) Have had surgery performed within the 12-hour period immediately preceding the study drug infusion, or are postoperative with evidence of active bleeding, or have planned or anticipated surgery during the infusion period Are not expected to survive 28 days given their preexisting uncorrectable medical condition

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

City

Loma Linda

State/Province

California

ZIP/Postal Code

92350

Country

United States

Facility Name

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80920

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80204

Country

United States

Facility Name

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66604

Country

United States

Facility Name

City

Hazard

State/Province

Kentucky

ZIP/Postal Code

41701

Country

United States

Facility Name

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48912

Country

United States

Facility Name

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

Facility Name

City

Missoula

State/Province

Montana

ZIP/Postal Code

59802

Country

United States

Facility Name

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11215

Country

United States

Facility Name

City

Staten Island

State/Province

New York

ZIP/Postal Code

10305

Country

United States

Facility Name

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27403

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15240

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

City

Garran

State/Province

Australian Capital Territory

ZIP/Postal Code

2605

Country

Australia

Facility Name

City

Newcastle

State/Province

New South Wales

ZIP/Postal Code

2305

Country

Australia

Facility Name

City

St. Leonards

State/Province

New South Wales

ZIP/Postal Code

2065

Country

Australia

Facility Name

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

City

Box Hill

State/Province

Victoria

ZIP/Postal Code

3128

Country

Australia

Facility Name

City

Epping

State/Province

Victoria

ZIP/Postal Code

3076

Country

Australia

Facility Name

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3050

Country

Australia

Facility Name

City

Antwerpen

ZIP/Postal Code

2060

Country

Belgium

Facility Name

City

Antwerp

ZIP/Postal Code

2020

Country

Belgium

Facility Name

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

City

LiÃ¨ge

ZIP/Postal Code

4000

Country

Belgium

Facility Name

City

Ottignies

ZIP/Postal Code

1340

Country

Belgium

Facility Name

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Facility Name

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

City

Belo Horizonte

ZIP/Postal Code

30140-093

Country

Brazil

Facility Name

City

Joinville

ZIP/Postal Code

89202-050

Country

Brazil

Facility Name

City

Londrina

ZIP/Postal Code

86038

Country

Brazil

Facility Name

City

Porto Alegre

ZIP/Postal Code

90610-970

Country

Brazil

Facility Name

City

Sao Jose Rio Preto

ZIP/Postal Code

15090

Country

Brazil

Facility Name

City

SÃ£o Paulo

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

Facility Name

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

Facility Name

City

Thunder Bay

State/Province

Ontario

ZIP/Postal Code

P7B 6V4

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H4J 1C5

Country

Canada

Facility Name

City

Sherbrook

State/Province

Quebec

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

City

Brno

ZIP/Postal Code

656 91

Country

Czech Republic

Facility Name

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czech Republic

Facility Name

City

Olomouc

ZIP/Postal Code

775 20

Country

Czech Republic

Facility Name

City

Plzen

ZIP/Postal Code

304 60

Country

Czech Republic

Facility Name

City

Prague

ZIP/Postal Code

128 08

Country

Czech Republic

Facility Name

City

Usti Nad Labem

ZIP/Postal Code

40113

Country

Czech Republic

Facility Name

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

Facility Name

City

Jyvaskyla

ZIP/Postal Code

40620

Country

Finland

Facility Name

City

Kuopio

ZIP/Postal Code

70211

Country

Finland

Facility Name

City

Lahti

ZIP/Postal Code

15850

Country

Finland

Facility Name

City

Seinajoki

ZIP/Postal Code

60220

Country

Finland

Facility Name

City

Tampere

ZIP/Postal Code

33520

Country

Finland

Facility Name

City

Angers

ZIP/Postal Code

49933

Country

France

Facility Name

City

Argenteuil

ZIP/Postal Code

95107

Country

France

Facility Name

City

Bobigny

ZIP/Postal Code

93009

Country

France

Facility Name

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

City

La Roche Sur Yon

ZIP/Postal Code

85000

Country

France

Facility Name

City

Le Kremlin Bicetre

ZIP/Postal Code

94275

Country

France

Facility Name

City

Limoges

ZIP/Postal Code

87042

Country

France

Facility Name

City

Lyon

ZIP/Postal Code

69437

Country

France

Facility Name

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

City

Nimes

ZIP/Postal Code

30029

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

City

Poissy

ZIP/Postal Code

78300

Country

France

Facility Name

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

City

Pringy

ZIP/Postal Code

74370

Country

France

Facility Name

City

Rennes

ZIP/Postal Code

35033

Country

France

Facility Name

City

Saint Michel

ZIP/Postal Code

16 470

Country

France

Facility Name

City

Saint-Etienne

ZIP/Postal Code

42055

Country

France

Facility Name

City

Toulon

ZIP/Postal Code

83056

Country

France

Facility Name

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

City

Vandoeuvre-Les-Nancy

ZIP/Postal Code

54500

Country

France

Facility Name

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

City

Augsburg

ZIP/Postal Code

86156

Country

Germany

Facility Name

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

City

Gottingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

City

Munich

ZIP/Postal Code

81377

Country

Germany

Facility Name

City

Bangalore

ZIP/Postal Code

560 002

Country

India

Facility Name

City

New Delhi

ZIP/Postal Code

110 025

Country

India

Facility Name

City

Pune

ZIP/Postal Code

411004

Country

India

Facility Name

City

Catania

ZIP/Postal Code

95124

Country

Italy

Facility Name

City

Firenze

ZIP/Postal Code

50143

Country

Italy

Facility Name

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

City

Monza

ZIP/Postal Code

20052

Country

Italy

Facility Name

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

City

Padova

ZIP/Postal Code

35127

Country

Italy

Facility Name

City

Rome

ZIP/Postal Code

00168

Country

Italy

Facility Name

City

Torino

ZIP/Postal Code

10126

Country

Italy

Facility Name

City

Varese

ZIP/Postal Code

21100

Country

Italy

Facility Name

City

Mexico City

ZIP/Postal Code

07760

Country

Mexico

Facility Name

City

Tlalpan

ZIP/Postal Code

14000

Country

Mexico

Facility Name

City

Arnhem

ZIP/Postal Code

6815 AD

Country

Netherlands

Facility Name

City

Ede

ZIP/Postal Code

6716 RP

Country

Netherlands

Facility Name

City

Nijmegen

ZIP/Postal Code

8525 GA

Country

Netherlands

Facility Name

City

Auckland

ZIP/Postal Code

1640

Country

New Zealand

Facility Name

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

City

Grafton

ZIP/Postal Code

1023

Country

New Zealand

Facility Name

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

Facility Name

City

Wellington

ZIP/Postal Code

6022

Country

New Zealand

Facility Name

City

Lisbon

ZIP/Postal Code

1449-005

Country

Portugal

Facility Name

City

Porto

ZIP/Postal Code

4202-451

Country

Portugal

Facility Name

City

Alcala De Henares

ZIP/Postal Code

28805

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

City

Burgos

ZIP/Postal Code

9005

Country

Spain

Facility Name

City

Getafe

ZIP/Postal Code

28905

Country

Spain

Facility Name

City

Las Palmas

ZIP/Postal Code

35010

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

City

Murcia

ZIP/Postal Code

30008

Country

Spain

Facility Name

City

Palma De Mallorca

ZIP/Postal Code

7010

Country

Spain

Facility Name

City

Sabadell

ZIP/Postal Code

8208

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41007

Country

Spain

Facility Name

City

Tortosa

ZIP/Postal Code

43500

Country

Spain

Facility Name

City

Valladolid

ZIP/Postal Code

47012

Country

Spain

Facility Name

City

Lugano

ZIP/Postal Code

CH-69100

Country

Switzerland

Facility Name

City

St Gallen

ZIP/Postal Code

CH-9007

Country

Switzerland

Facility Name

City

Zurich

ZIP/Postal Code

CH-8091

Country

Switzerland

Facility Name

City

Bristol

State/Province

Avon

ZIP/Postal Code

BS2 8HW

Country

United Kingdom

Facility Name

City

Plymouth

State/Province

Devon

ZIP/Postal Code

PL6 8DH

Country

United Kingdom

Facility Name

City

Chelmsford

State/Province

Essex

ZIP/Postal Code

CM2 5ET

Country

United Kingdom

Facility Name

City

Portsmouth

State/Province

Hampshire

ZIP/Postal Code

P06 3LY

Country

United Kingdom

Facility Name

City

Southampton

State/Province

Hants

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

City

Edinburgh

State/Province

Scotland

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Facility Name

City

Glasgow

State/Province

Scotland

ZIP/Postal Code

G42 9TY

Country

United Kingdom

Facility Name

City

Guildford

State/Province

Surrey

ZIP/Postal Code

GU2 7XX

Country

United Kingdom

Facility Name

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Facility Name

City

Chichester

State/Province

West Sussex

ZIP/Postal Code

PO19 6SE

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

SW17 0QY

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25928214

Citation

Povoa P, Salluh JI, Martinez ML, Guillamat-Prats R, Gallup D, Al-Khalidi HR, Thompson BT, Ranieri VM, Artigas A. Clinical impact of stress dose steroids in patients with septic shock: insights from the PROWESS-Shock trial. Crit Care. 2015 Apr 28;19(1):193. doi: 10.1186/s13054-015-0921-x.

Results Reference

derived

PubMed Identifier

22616830

Citation

Ranieri VM, Thompson BT, Barie PS, Dhainaut JF, Douglas IS, Finfer S, Gardlund B, Marshall JC, Rhodes A, Artigas A, Payen D, Tenhunen J, Al-Khalidi HR, Thompson V, Janes J, Macias WL, Vangerow B, Williams MD; PROWESS-SHOCK Study Group. Drotrecogin alfa (activated) in adults with septic shock. N Engl J Med. 2012 May 31;366(22):2055-64. doi: 10.1056/NEJMoa1202290. Epub 2012 May 22.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of Drotrecogin Alfa (Activated) in Adult Patients With Septic Shock

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