Clinical trial NCT00034476: A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis
Official title: A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients With Severe Sepsis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sepsis
Keywords: Sepsis, sPLA2 Inhibitor
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2002-04-30
Enrollment: 466
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Berkeley
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Orange
country: United States
state: California
city: San Diego
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Brandon
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Oak Park
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Iowa
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Lake Charles
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Portland
country: United States
state: Maine
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Minneapolis
country: United States
state: Minnesota
city: St. Lous
country: United States
state: Missouri
city: Reno
country: United States
state: Nevada
city: East Orange
country: United States
state: New Jersey
city: New Brunswick
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Great Neck
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Greensboro
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Pittsburg
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Memphis
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Falls Church
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Brussels
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Liege
country: Belgium
city: Ottignies
country: Belgium
city: Yvior
country: Belgium
city: Budapest
country: Hungary
city: Debrecend
country: Hungary
city: Debrecen
country: Hungary
city: Miskolc
country: Hungary
city: Pecs
country: Hungary
city: Szeged
country: Hungary
city: Vac
country: Hungary
city: Apeldoorn
country: Netherlands
city: Breda
country: Netherlands
city: Den Bosch
country: Netherlands
city: Groningen
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Gdansk
country: Poland
city: Krakow-Nowa Huta
country: Poland
city: Poznan
country: Poland
city: Sosnowiec
country: Poland
city: Szczecin
country: Poland
city: Warsaw
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
Study officials:
References: