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

This study has been completed.
Information provided by:
ICOS Corporation
ClinicalTrials.gov Identifier:
First received: August 1, 2002
Last updated: June 23, 2005
Last verified: January 2004
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
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:

Further study details as provided by ICOS Corporation:

Study Start Date: May 2002

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

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

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 
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:
Lung Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Systemic Inflammatory Response Syndrome
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016