A Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis - Tabular View

Tracking Information
First Received Date ^ICMJE	August 1, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE	May 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00042588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis
Official Title ^ICMJE	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis
Brief Summary	The objective of this study is to demonstrate the safety and efficacy of IC14 in the treatment of hospitalized patients with community-acquired pneumonia and sepsis.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Pneumonia Sepsis
Intervention ^ICMJE	Drug: Recombinant Chimeric Monoclonal Antibody
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
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Current diagnosis of community-acquired pneumonia. Evidence of systemic inflammatory response to infection. Exclusion Criteria: Atypical or viral pneumonia based on clinical or epidemiologic suspicion by the investigator. Presence of organ failure.
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

Administrative Information
NCT ID ^ICMJE	NCT00042588
Responsible Party
Study ID Numbers ^ICMJE	EPN01, EPN01
Study Sponsor ^ICMJE	ICOS Corporation
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	ICOS Corporation
Verification Date	January 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP