NCT00037687

Brief Summary

The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all cause mortality in patients with severe sepsis.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for phase_3 sepsis

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_3 sepsis

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2002

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 2003

First QC Date

May 20, 2002

Last Update Submit

June 23, 2005

Conditions

Sepsis

Keywords

Severe sepsisPlatelet-activating factor acetylhydrolase

Interventions

rPAF-AHDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of severe sepsis
  • At least 18 years old
  • Patient or legally authorized representative able to provide informed consent

You may not qualify if:

  • Severe lung injury (acute respiratory distress syndrome)
  • Immunocompromised
  • Severe liver disease
  • Inflammation of the pancreas, organ rejection, or burns to more than 30% of body
  • Enrolled in another clinical trial
  • Already participated in this or other rPAF-AH study
  • There is not a commitment to aggressive treatment
  • Has a disease with life expectancy less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mary E. Lonien, M.S.

Bothell, Washington, 98021, United States

Location

Related Publications (1)

  • The Pafase Phase II ARDS Prevention Study Group. Recombinant platelet-activating factor acetylhydrolase (Pafase) decreases the incidence of acute respiriatory distress syndrome (ARDS) and 28 day all cause mortality (Abstract). Intensive Care Med (2000); 26: S321.

    BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 20, 2002

First Posted

May 21, 2002

Study Start

April 1, 2001

Study Completion

December 1, 2004

Last Updated

June 24, 2005

Record last verified: 2003-01

Locations

US(1)