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

Tracking Information
First Received Date ^ICMJE	April 29, 2002
Last Updated Date	July 18, 2006
Start Date ^ICMJE	October 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00034476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis
Official Title ^ICMJE	A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis
Brief Summary	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.
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Sepsis
Intervention ^ICMJE	Drug: sPLA2 Inhibitor
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	466
Completion Date	October 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Belgium, Hungary, Netherlands, Poland

Administrative Information
NCT ID ^ICMJE	NCT00034476
Responsible Party
Study ID Numbers ^ICMJE	1641, J4A-MC-EZZI
Study Sponsor ^ICMJE	Eli Lilly and Company
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Eli Lilly and Company
Verification Date	July 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP