Additional identifiers
EudraCT 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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial 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
Phase
Phase III
Drug names
Recombinant human activated protein C
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/1998
Overall trial end date
01/06/2000
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
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
Trial participating centre
DC6072
Indianapolis
46285
United States of America
Funders
Funder type
Industry
Funder name
Eli Lilly and Company (USA)
Alternative name(s)
Lilly
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2001 results in http://www.ncbi.nlm.nih.gov/pubmed/11236773
2. 2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15025782
Publication citations
-
Results
Bernard GR, Vincent JL, Laterre PF, LaRosa SP, Dhainaut JF, Lopez-Rodriguez A, Steingrub JS, Garber GE, Helterbrand JD, Ely EW, Fisher CJ, , Efficacy and safety of recombinant human activated protein C for severe sepsis., N. Engl. J. Med., 2001, 344, 10, 699-709, doi: 10.1056/NEJM200103083441001.
-
Results
Kinasewitz GT, Yan SB, Basson B, Comp P, Russell JA, Cariou A, Um SL, Utterback B, Laterre PF, Dhainaut JF, , Universal changes in biomarkers of coagulation and inflammation occur in patients with severe sepsis, regardless of causative micro-organism [ISRCTN74215569]., Crit Care, 2004, 8, 2, R82-90, doi: 10.1186/cc2459.