Condition category
Infections and Infestations
Date applied
06/01/2004
Date assigned
07/01/2004
Last edited
08/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr William Macias

ORCID ID

Contact details

DC6072
Eli Lilly and Company
307 E. McCarty St.
Indianapolis
46285
United States of America

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

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

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

  1. 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.

  2. 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.

Additional files

Editorial Notes