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

This study has been completed.
Sponsor:
Information provided by:
ICOS Corporation
ClinicalTrials.gov Identifier:
NCT00042588
First received: August 1, 2002
Last updated: June 23, 2005
Last verified: January 2004
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

MedlinePlus related topics: Pneumonia Sepsis
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

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

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013