A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

This study has been completed.

First Received on April 29, 2002. Last Updated on July 18, 2006 History of Changes

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00034476

Purpose

The purpose of this study is to determine whether the administration of the study drug is effective in increasing the chance of survival in patients with severe sepsis. Patients entered into this study will be randomly assigned to one of two treatment groups. Patients in each treatment group will be given either the study drug or placebo as a continuous infusion directly into the bloodstream through a catheter placed in one of the patient's veins.

The study drug is an investigational drug that is still in development. It has been studied in approximately 30 healthy subjects, approximately 30 patients with either kidney failure or arthritis, and approximately 600 patients with severe sepsis. Patient participation in this study will last for about one month.

Condition	Intervention	Phase
Sepsis	Drug: sPLA2 Inhibitor	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Estimated Enrollment:	466
Study Start Date:	October 2001
Estimated Study Completion Date:	October 2002

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria: Patients must

show evidence of acute infection
meet specified time windows
be 18 years of age or older

Exclusion Criteria: Patients must not

have low white blood cell count
have undergone certain organ transplants
be HIV positive
be pregnant or breast feeding
have severe underlying medical problems

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00034476

Show 87 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00034476 History of Changes
Other Study ID Numbers:	1641, J4A-MC-EZZI
Study First Received:	April 29, 2002
Last Updated:	July 18, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Sepsis, sPLA2 Inhibitor

Additional relevant MeSH terms:

Sepsis
Toxemia
Infection

Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2012