Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
F1K-MC-EVAD
Study information
Scientific title
Acronym
PROWESS
Study hypothesis
Not provided at time of registration
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Severe sepsis
Intervention
Recombinant human activated protein C (tradename - Xigris, generic name - drotrecogin alfa [activated]) versus placebo.
This trial took place at 164 hospitals in 11 countries.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase III
Drug/device/biological/vaccine name(s)
Recombinant human activated protein C
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/07/1998
Overall study end date
01/06/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type(s)
Patient
Age group
Not Specified
Sex
Both
Target number of participants
1,690
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/07/1998
Recruitment end date
01/06/2000
Locations
Countries of recruitment
Belgium, Canada, France, Spain, United States of America
Study participating centre
DC6072
Indianapolis
46285
United States of America
Sponsor information
Organisation
Eli Lilly and Company (USA)
Sponsor details
DC6072
307 E. McCarty Street
Indianapolis
46285
United States of America
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Eli Lilly and Company (USA)
Alternative name(s)
Lilly, Eli Lilly & Company, Eli Lilly & Co., Eli Lilly And Co
Funding Body Type
government organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/03/2001 | Yes | No | |
| Results article | results | 01/04/2004 | Yes | No |