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

This study has been completed.

First Received: August 1, 2002 Last Updated: June 23, 2005 History of Changes

Sponsored by:	ICOS Corporation
Information provided by:	ICOS Corporation
ClinicalTrials.gov Identifier:	NCT00042588

Purpose

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.

Condition	Intervention	Phase
Pneumonia Sepsis	Drug: Recombinant Chimeric Monoclonal Antibody	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2 Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia Sepsis

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by ICOS Corporation:

Study Start Date:

May 2002

Eligibility

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042588

Locations

United States, Washington
ICOS Corporation
Bothell, Washington, United States, 98021

Sponsors and Collaborators

ICOS Corporation

More Information

No publications provided

Study ID Numbers:	EPN01, EPN01
Study First Received:	August 1, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00042588 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ICOS Corporation:

Safety and Efficacy
Community-Acquired Pneumonia, Sepsis

Study placed in the following topic categories:

Antibodies, Monoclonal
Systemic Inflammatory Response Syndrome
Antibodies
Sepsis
Immunologic Factors
Respiratory Tract Infections

Respiratory Tract Diseases
Lung Diseases
Pneumonia
Immunoglobulins
Inflammation

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Immunologic Factors
Physiological Effects of Drugs
Infection
Pharmacologic Actions
Inflammation
Antibodies, Monoclonal

Sepsis
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Pneumonia

ClinicalTrials.gov processed this record on July 02, 2009