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

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ClinicalTrials.gov Identifier: NCT00042588
Recruitment Status : Completed
First Posted : August 5, 2002
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
ICOS Corporation

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.

Condition or disease Intervention/treatment Phase
Pneumonia Sepsis Drug: Recombinant Chimeric Monoclonal Antibody Phase 2

Study Type : Interventional  (Clinical Trial)
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
Study Start Date : May 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia Sepsis
U.S. FDA Resources





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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.

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

ClinicalTrials.gov Identifier: NCT00042588     History of Changes
Other Study ID Numbers: EPN01
EPN01
First Posted: August 5, 2002    Key Record Dates
Last Update Posted: June 24, 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