Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bothell, Washington 98021


Purpose:

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.


Study summary:

This study is a randomized, double-blind, placebo-controlled, multicenter study of rPAF-AH compared to placebo in patients with severe sepsis. Eligible patients from investigative sites located throughout the United States and other countries will be randomized to receive either rPAF-AH or placebo administered daily for five consecutive days by intravenous (IV) infusion. All patients will be evaluated for safety and efficacy endpoints over 28 days. A follow-up evaluation will occur approximately 6 months after Day 28 to assess functional status and quality of life.


Criteria:

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


NCT ID:

NCT00037687


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Bothell, Washington 98021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.