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NCT00042588 Clinical Trial

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

Sepsis Clinical Trial

Official title:
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Hospitalized Patients With Community-Acquired Pneumonia and Sepsis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00042588
Other study ID # EPN01
Secondary ID EPN01
Status Completed
Phase Phase 2
First received August 1, 2002
Last updated June 23, 2005
Start date May 2002

Study information
Verified date January 2004
Source ICOS Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Recombinant Chimeric Monoclonal Antibody

Locations
Country Name City State
United States ICOS Corporation Bothell Washington

Sponsors (1)
Lead Sponsor Collaborator
ICOS Corporation

Country where clinical trial is conducted

United States, 

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