Back to resultsA Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis
Primary Purpose
Pneumonia, Sepsis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Recombinant Chimeric Monoclonal Antibody
Sponsored by
About this trial
This is an interventional treatment trial for Pneumonia focused on measuring Safety and Efficacy, Community-Acquired Pneumonia, Sepsis
Eligibility 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.
Sites / Locations
- ICOS Corporation
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00042588
Brief Title
A Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis
Official Title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2004
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
ICOS Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Sepsis
Keywords
Safety and Efficacy, Community-Acquired Pneumonia, Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Recombinant Chimeric Monoclonal Antibody
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
ICOS Corporation
City
Bothell
State/Province
Washington
ZIP/Postal Code
98021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis
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