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 |
| Protocol serial number | F1K-MC-EVAD |
| Sponsor | Eli Lilly and Company (USA) |
| Funder | Eli Lilly and Company (USA) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Recombinant human activated protein C |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 1690 |
| 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| 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 |
