SepsisPhase 3NCT00604214

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

A Phase 3 study testing Drotrecogin alfa (activated) in people with Sepsis, run by Eli Lilly and Company at 150 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis
What is being tested?: Drotrecogin alfa (activated)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,696 participants
Where: 150 sitesin 18 countries
Study dates: Mar 2008to Feb 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

150 sites in 18 countries.

Country

City, postcode or hospital

150 sites in 18 countries

United States23 sites

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Birmingham, Alabama, 35294
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Brooklyn, New York, 11215
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Chesterfield, Missouri, 63017
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Chicago, Illinois, 60611
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Colorado Springs, Colorado, 80920
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Denver, Colorado, 80204
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Greensboro, North Carolina, 27403
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Hazard, Kentucky, 41701
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Idaho Falls, Idaho, 83404
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Iowa City, Iowa, 52242
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Lansing, Michigan, 48912
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Loma Linda, California, 92350
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Long Beach, California, 90806
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Missoula, Montana, 59802
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Norfolk, Virginia, 23507
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Philadelphia, Pennsylvania, 19107
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Pittsburgh, Pennsylvania, 15240
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Portland, Oregon, 97239
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San Antonio, Texas, 78229
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San Diego, California, 92123
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St Louis, Missouri, 63131
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Staten Island, New York, 10305
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Topeka, Kansas, 66604

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France23 sites

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Angers, 49933
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Argenteuil, 95107
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Bobigny, 93009
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Bordeaux, 33076
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Dijon, 21079
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La Roche-sur-Yon, 85000
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Le Kremlin-Bicêtre, 94275
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Limoges, 87042
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Lyon, 69437
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Montpellier, 34295
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Nantes, 44093
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Nice, 06202
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Nîmes, 30029
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Paris, 75010
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Poissy, 78300
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Poitiers, 86021
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Pringy, 74370
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Rennes, 35033
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Saint-Etienne, 42055
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Saint-Michel, 16 470
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Toulon, 83056
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Tours, 37044
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Vandœuvre-lès-Nancy, 54500

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Spain12 sites

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Alcalá de Henares, 28805
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Barcelona, 08035
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Burgos, 9005
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Getafe, 28905
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Las Palmas, 35010
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Madrid, 28040
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Murcia, 30008
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Palma de Mallorca, 7010
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Sabadell, 8208
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Seville, 41007
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Tortosa, 43500
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Valladolid, 47012

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Belgium11 sites

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Antwerp, 2020
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Antwerp, 2060
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Brussels, 1200
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Edegem, 2650
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Genk, 3600
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Leuven, 3000
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LiÃ¨ge, 4000
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Ottignies, 1340
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Roeselare, 8800
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Wilrijk, 2610
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Yvoir, 5530

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United Kingdom11 sites

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Birmingham, West Midlands, B15 2TH
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Bristol, Avon, BS2 8HW
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Chelmsford, Essex, CM2 5ET
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Chichester, West Sussex, PO19 6SE
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Edinburgh, Scotland, EH4 2XU
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Glasgow, Scotland, G42 9TY
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Guildford, Surrey, GU2 7XX
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London, SW17 0QY
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Plymouth, Devon, PL6 8DH
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Portsmouth, Hampshire, P06 3LY
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Southampton, Hants, SO16 6YD

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Australia10 sites

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Adelaide, South Australia, 5000
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Box Hill, Victoria, 3128
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Epping, Victoria, 3076
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Garran, Australian Capital Territory, 2605
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Heidelberg, Victoria, 3084
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Herston, Queensland, 4029
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Melbourne, Victoria, 3004
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Newcastle, New South Wales, 2305
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Parkville, Victoria, 3050
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St Leonards, New South Wales, 2065

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Italy9 sites

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Catania, 95124
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Florence, 50143
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Milan, 20132
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Monza, 20052
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Novara, 28100
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Padova, 35127
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Rome, 00168
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Torino, 10126
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Varese, 21100

Other trials in Italy

Germany8 sites

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Aachen, 52074
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Augsburg, 86156
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Berlin, 13125
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Göttingen, 37075
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Hamburg, 20246
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Heidelberg, 69120
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Kiel, 24105
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Munich, 81377

Other trials in Germany

Canada7 sites

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Calgary, Alberta, T2N 2T9
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Montreal, Quebec, H4J 1C5
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Sherbrook, Quebec, J1H 5N4
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Thunder Bay, Ontario, P7B 6V4
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Toronto, Ontario, M4N 3M5
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Vancouver, British Columbia, V5Z 1M9
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Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Brazil6 sites

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Belo Horizonte, 30140-093
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Joinville, 89202-050
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Londrina, 86038
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Porto Alegre, 90610-970
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SÃ£o Paulo, 05403-000
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Sao Jose Rio Preto, 15090

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Czechia6 sites

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Brno, 656 91
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Hradec Králové, 500 05
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Olomouc, 775 20
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Pilsen, 304 60
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Prague, 128 08
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Ústí nad Labem, 40113

Other trials in Czechia

Finland6 sites

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Helsinki, 00029
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Jyväskylä, 40620
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Kuopio, 70211
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Lahti, 15850
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Seinäjoki, 60220
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Tampere, 33520

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New Zealand5 sites

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Auckland, 1640
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Christchurch, 8011
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Grafton, 1023
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Hamilton, 3204
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Wellington, 6022

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India3 sites

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Bangalore, 560 002
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New Delhi, 110 025
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Pune, 411004

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Netherlands3 sites

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Arnhem, 6815 AD
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Ede, 6716 RP
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Nijmegen, 8525 GA

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Switzerland3 sites

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Lugano, CH-69100
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Sankt Gallen, CH-9007
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Zurich, CH-8091

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Mexico2 sites

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Mexico City, 07760
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Tlalpan, 14000

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Portugal2 sites

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Lisbon, 1449-005
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Porto, 4202-451

Other trials in Portugal

About this study

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

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.

Conditions: Sepsis
Being tested: Drotrecogin alfa (activated), Placebo
Keywords: Sepsis, Septic shock
Medical subject headings: Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drotrecogin alfa (activated)Drug
Also called LY203638, Xigris
24 microgram/kilogram/hour, intravenous, 96 hours (hr)
PlaceboDrug
0.9% sodium chloride, intravenous, 96 hours

Study groups in NCT00604214
Study group	Role	What they receive
Drotrecogin alfa (activated)	Experimental	Not described Receives: Drug: Drotrecogin alfa (activated)
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

28-Day All-Cause Mortality
Expressed as percentage of participants who died from any cause at Day 28 endpoint.
Measured: Day 28

Secondary outcomes (11)

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%).
Measured: Day 28
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.
Measured: Day 1 through Day 28
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.
Measured: Day 1 through Day 28
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.
Measured: Day 1 through Day 28
90-Day Mortality
Expressed as percentage of participants who died from any cause at Day 90 endpoint.
Measured: Day 90
180-Day Mortality
Expressed as percentage of participants who died from any cause at Day 180 endpoint.
Measured: Day 180
Median Survival Time
Measured: Day 180
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.
Measured: Baseline and Days 28 and 90 and 180
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).
Measured: Baseline and Days 28 and 90 and 180
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.
Measured: Baseline and Days 28 and 90 and 180
Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint
Measured: Baseline through Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Feb 2012

First posted30 Jan 2008 (estimated)
Study startMar 2008
Primary completionSep 2011
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SepsisStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,696 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00604214
Sponsor's protocol ID: 11940
Other IDs: F1K-MC-EVDP
Status last verified: Aug 2012
First submitted: 24 Jan 2008
Last updated: 18 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 25928214
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.
PubMed 22616830

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00604214
Acronym / sponsor ID: 11940
Conditions: Sepsis
Keywords: Sepsis, Septic shock
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,696 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Sep 2011 (actual)
Study completion: Feb 2012 (actual)
First posted: 30 Jan 2008 (estimated)
Results: Posted 18 Sep 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Drotrecogin alfa (activated)	Experimental	Drug: Drotrecogin alfa (activated)
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Drotrecogin alfa (activated)Also: LY203638, Xigris24 microgram/kilogram/hour, intravenous, 96 hours (hr)	Drug	Drotrecogin alfa (activated)
Placebo0.9% sodium chloride, intravenous, 96 hours	Drug	Placebo

Primary outcome

28-Day All-Cause Mortality
Time frame: Day 28
Expressed as percentage of participants who died from any cause at Day 28 endpoint.

11 secondary outcomes

28-Day All-Cause Mortality in Participants With Severe Protein C Deficiency
Time frame: Day 28
Average Cardiovascular Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
Time frame: Day 1 through Day 28
Average Respiratory Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
Time frame: Day 1 through Day 28
Average Renal Sequential Organ Failure Assessment (SOFA) Score Day 1 Through Day 28
Time frame: Day 1 through Day 28
90-Day Mortality
Time frame: Day 90
180-Day Mortality
Time frame: Day 180
Median Survival Time
Time frame: Day 180
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Visual Analog Scale (VAS) Scores at Baseline, Days 28, 90 and 180
Time frame: Baseline and Days 28 and 90 and 180
EuroQoL Questionnaire-5 Dimensions (EQ-5D) Total Scores at Baseline, Days 28, 90 and 180
Time frame: Baseline and Days 28 and 90 and 180
Quality of Life Short Form-12 (SF-12) Scores at Baseline, Days 28, 90 and 180
Time frame: Baseline and Days 28 and 90 and 180
Percentage of Participants Discontinued Due to Adverse Events Any Time From Baseline Through Day 28 Endpoint
Time frame: Baseline through Day 28

Results and safety

Results posted to the registry on 18 Sep 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Drotrecogin Alfa (Activated)	851	623
Placebo	845	632

Primary outcome: 28-Day All-Cause Mortality

Time frame: Day 28. Number. Unit: percentage of participants

Measure	Drotrecogin Alfa (Activated) n = 846	Placebo n = 834
Value	26.4	24.2

Drotrecogin Alfa (Activated) vs Placebo: Risk Ratio (RR): 1.088 (95% CI 0.923 to 1.283), p = 0.313, Chi-squared

Population analysed: All randomized participants with known mortality status at Day 28.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Day 0 to Day 28. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Drotrecogin Alfa (Activated)	119 of 833 (14.3%)	151 of 833 (18.1%)	Not reported
Placebo	96 of 833 (11.5%)	119 of 833 (14.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25928214Povoa 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.
Derived from this study: PubMed 22616830Ranieri 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.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Sepsis

Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

150 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Drotrecogin alfa (activated) in people with Sepsis, run by Eli Lilly and Company at 150 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in United States, France, Spain, Belgium, United Kingdom and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-Day All-Cause Mortality (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00604214, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2012.