A phase 3 study to determine the efficacy and safety of recombinant human activated protein C in severe sepsis
| ISRCTN | ISRCTN74215569 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74215569 |
| Secondary identifying numbers | F1K-MC-EVAD |
- Submission date
- 06/01/2004
- Registration date
- 07/01/2004
- Last edited
- 08/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr William Macias
Scientific
Scientific
DC6072
Eli Lilly and Company
307 E. McCarty St.
Indianapolis
46285
United States of America
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | PROWESS |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 01/06/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 1,690 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/1998 |
| Date of final enrolment | 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
46285
United States of America
Sponsor information
Eli Lilly and Company (USA)
Industry
Industry
DC6072
307 E. McCarty Street
Indianapolis
46285
United States of America
"ROR" |
https://ror.org/00cpsd622 |
|---|
Funders
Funder type
Industry
Eli Lilly and Company (USA)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Lilly, Eli Lilly & Company, Eli Lilly & Co., Eli Lilly And Co
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
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 |
