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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00042588
First Posted: August 5, 2002
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
ICOS Corporation
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:


Further study details as provided by ICOS Corporation:

Study Start Date: May 2002
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00042588


Locations
United States, Washington
ICOS Corporation
Bothell, Washington, United States, 98021
Sponsors and Collaborators
ICOS Corporation
  More Information

ClinicalTrials.gov Identifier: NCT00042588     History of Changes
Other Study ID Numbers: EPN01
First Submitted: August 1, 2002
First Posted: August 5, 2002
Last Update Posted: December 9, 2005
Last Verified: January 2004

Keywords provided by ICOS Corporation:
Safety and Efficacy
Community-Acquired Pneumonia, Sepsis

Additional relevant MeSH terms:
Pneumonia
Sepsis
Toxemia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs